Clinical Trial Results:
A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.
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Summary
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EudraCT number |
2011-003208-19 |
Trial protocol |
GB CZ |
Global end of trial date |
05 Aug 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
23 Sep 2018
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First version publication date |
23 Sep 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GWID10160
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01562314 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GW Research Ltd
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Sponsor organisation address |
Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, United Kingdom, CB24 9BZ
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Public contact |
Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, medinfo@gwpharm.com
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Scientific contact |
Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, medinfo@gwpharm.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Mar 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Aug 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Aug 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to evaluate the efficacy of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a MAYO score of 2 or less (with no sub-score >1) after 10 weeks treatment.
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted. No study procedures were performed on study candidates until written consent had been obtained from the participant. The informed consent form, protocol, and amendments for this study were submitted to and approved by the institutional review board or independent ethics committee at each participating study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 May 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
56
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Participants were screened for eligibility over a period of 7 days. | |||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer, Assessor | |||||||||||||||||||||||||||||||||
Blinding implementation details |
To maintain blinding throughout, all capsule medication was formulated in such a way as to disguise the appearance, smell and taste of the active materials by the use of identical excipients and capsule shells. The maximum number of dose units administered was identical in both treatment groups.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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GWP42003 | |||||||||||||||||||||||||||||||||
Arm description |
GWP42003 was administered orally at a dose of 50 milligrams (mg) up to 250 mg, twice daily (BID), in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GWP42003
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Investigational medicinal product code |
GWP42003
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Other name |
Cannabidiol (CBD), Botanical Drug Substance (BDS)
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
1 to 5 50 mg capsules taken BID
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Arm title
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Placebo | |||||||||||||||||||||||||||||||||
Arm description |
Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week. | |||||||||||||||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
Placebo control
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
1 to 5 matching capsules taken BID
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Baseline characteristics reporting groups
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Reporting group title |
GWP42003
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Reporting group description |
GWP42003 was administered orally at a dose of 50 milligrams (mg) up to 250 mg, twice daily (BID), in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GWP42003
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Reporting group description |
GWP42003 was administered orally at a dose of 50 milligrams (mg) up to 250 mg, twice daily (BID), in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week. | ||
Subject analysis set title |
GWP42003 - ITT Analysis Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized.
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Subject analysis set title |
Placebo - ITT Analysis Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized.
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Subject analysis set title |
GWP42003 - PP Analysis Set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All participants without protocol violations that compromised the assessments of efficacy.
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Subject analysis set title |
Placebo - PP Analysis Set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
All participants without protocol violations that compromised the assessments of efficacy.
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End point title |
Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT | |||||||||
End point description |
The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
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End point type |
Primary
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End point timeframe |
Baseline to End of Treatment (EOT) (10 weeks) or Early Termination (ET)
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Statistical analysis title |
Mayo Score Of 2 Or Less - ITT Analysis Set | |||||||||
Comparison groups |
GWP42003 - ITT Analysis Set v Placebo - ITT Analysis Set
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.7532 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
0.821
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
0.292 | |||||||||
upper limit |
2.309 | |||||||||
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End point title |
Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis Set | |||||||||
End point description |
The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
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End point type |
Primary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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Statistical analysis title |
Mayo Score Of 2 Or Less - PP Analysis Set | |||||||||
Comparison groups |
Placebo - PP Analysis Set v GWP42003 - PP Analysis Set
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Number of subjects included in analysis |
44
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.7032 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
1.3
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Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
0.419 | |||||||||
upper limit |
4.04 | |||||||||
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End point title |
Distribution On The PGAS At EOT | |||||||||||||||||||||
End point description |
The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0 = normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease).
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End point type |
Secondary
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End point timeframe |
EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Distribution On The PGAS At EOT - PP Analysis | |||||||||||||||||||||
End point description |
The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0 = normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease).
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End point type |
Secondary
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End point timeframe |
EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The PGAS Score | |||||||||||||||||||||
End point description |
The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0 = normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The PGAS Score - PP Analysis | |||||||||||||||||||||
End point description |
The PGAS required the physician to assess participants’ disease severity on a 4-point scale (0 = normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score | |||||||||||||||||||||
End point description |
The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with inflammatory bowel disease (IBD). Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status, and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The IBDQ Total Score - PP Analysis | |||||||||||||||||||||
End point description |
The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with IBD. Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status, and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number Of Participants Who Reported An Improvement In The Subject Global Impression Of Change (SGIC) Questionnaire At EOT | |||||||||||||||
End point description |
Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): “Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment.” Improvement was considered as very much better, much better, or minimally better.
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End point type |
Secondary
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End point timeframe |
Visit 4 (Day 43) to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Number Of Participants Who Reported An Improvement In The SGIC Questionnaire At EOT - PP Analysis | |||||||||||||||
End point description |
Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): “Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment.” Improvement was considered as very much better, much better, or minimally better.
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End point type |
Secondary
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End point timeframe |
Visit 4 (Day 43) to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency Numerical Rating Scale (NRS) | |||||||||||||||||||||
End point description |
Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (last 7 days) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency NRS - PP Analysis | |||||||||||||||||||||
End point description |
Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (last 7 days) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS | |||||||||||||||||||||
End point description |
Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (last 7 days) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS - PP Analysis | |||||||||||||||||||||
End point description |
Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (last 7 days) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The Mayo Total Score | |||||||||||||||||||||
End point description |
The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The Mayo Partial Score | |||||||||||||||||||||
End point description |
The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In Levels Of Fecal Calprotectin | |||||||||||||||||||||
End point description |
Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased.
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End point type |
Secondary
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The Mayo Total Score - PP Analysis | |||||||||||||||||||||
End point description |
The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.
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End point type |
Post-hoc
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In The Mayo Partial Score - PP Analysis Set | |||||||||||||||||||||
End point description |
The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.
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End point type |
Post-hoc
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Change From Baseline To EOT In Levels Of Fecal Calprotectin- PP Analysis | |||||||||||||||||||||
End point description |
Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased.
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End point type |
Post-hoc
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End point timeframe |
Baseline to EOT (10 weeks) or ET
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| No statistical analyses for this end point | ||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Post-dose on Day 1 through 14 days after the final dose (up to 85 days).
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Adverse event reporting additional description |
Safety analysis set: All randomized participants who received at least one dose of study drug and were analyzed according to the treatment received.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
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Reporting groups
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Reporting group title |
GWP42003
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Reporting group description |
GWP42003 was administered orally at a dose of 50 mg up to 250 mg, BID, in the fasted state in the morning and evening, for 10 weeks. Following randomization, participants entered a 2-week dose escalation period to achieve their maximum tolerated dose, up to 500 mg, and maintained this dose for the rest of the treatment period. Participants were then followed for 1 week. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo capsules matching the study drug were administered orally, BID, in the fasted state in the morning and evening, for 10 weeks. Participants were then followed for 1 week. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: This SAE affects only female participants. |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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02 Nov 2011 |
The amendment to this study updated contact details following GW Pharmaceuticals Ltd. office relocation. |
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24 Jun 2013 |
The amendment to this study amended the protocol to remove the lower dose limit of study drug. Topical treatments for ulcerative colitis within 2 weeks prior to screening were originally prohibited in the study protocol. This was changed so that participants on a stable dose of topical therapy for ulcerative colitis could be eligible in some circumstances. The amendment also divided the exclusion criterion 6.2.8 into 2 so that investigators could act at their discretion as to whether a participant with a history of significant psychiatric disorder or severe personality disorder was eligible for the study. Finally, the amendment resolved minor errors, inconsistencies and clarity issues.
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21 Aug 2013 |
The amendment to this study further amendment the Prohibited Therapy section of the protocol to disallow topical treatments for ulcerative colitis within the last 2 weeks prior to the screening endoscopy. The amendment also included 3 minor administrative corrections.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/29538683 |
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