Clinical Trial Results:
A randomised, double blind, placebo controlled, parallel group, dose ranging study of GWP42004 as add on to metformin in the treatment of participants with Type 2 diabetes.
Summary
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EudraCT number |
2013-001140-61 |
Trial protocol |
GB |
Global end of trial date |
29 Dec 2015
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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 |
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 |
GWDM1302
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02053272 | ||
WHO universal trial number (UTN) |
- | ||
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 |
29 Dec 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Dec 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Dec 2015
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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 |
To evaluate the efficacy of 2, 5 and 15 milligrams (mg) twice daily of GWP42004 compared with placebo by assessing the impact of treatment on glycaemic control in the treatment of participants with Type 2 diabetes.
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Protection of trial subjects |
This trial was conducted in compliance with International Conference on Harmonisation Good Clinical Practice guidelines for conducting, recording, and reporting trials, as well as for archiving essential documents. Consistent with ethical principles for the protection of human research participants, no study procedures were performed on study participants until written consent had been obtained from them. The informed consent form, protocol, and amendments for this trial were submitted to and approved by the Institutional Review Board or Ethics Committee at each participating trial site.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Mar 2014
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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 |
Romania: 166
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Country: Number of subjects enrolled |
United Kingdom: 41
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Worldwide total number of subjects |
207
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EEA total number of subjects |
207
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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) |
139
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From 65 to 84 years |
68
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Adult participants had been diagnosed with type 2 diabetes, received oral metformin (≥1000 mg/day) for ≥3 months prior to screening, maintained stable metformin dose for trial duration, had not taken insulin in the last year, had glycosylated haemoglobin A1c (HbA1c) levels >7% - ≤9%, and body mass index (BMI) >23 - <40 kilograms (kg)/metre (m)^2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Baseline, Treatment, Follow-up (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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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GWP42004, 2 mg twice daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GWP42004
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Investigational medicinal product code |
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Other name |
Δ9-tetrahydrocannabivarin
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
GWP42004 was presented as a hard gelatin capsule containing 2 mg GWP42004 (Δ9-tetrahydrocannabivarin) and excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - Federal Food, Drug, and Cosmetic (FD&C) blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.
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Arm title
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GWP42004, 5 mg twice daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GWP42004
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Investigational medicinal product code |
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Other name |
Δ9-tetrahydrocannabivarin
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
GWP42004 was presented as a hard gelatin capsule containing 5 mg GWP42004 (Δ9-tetrahydrocannabivarin) and excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - FD&C blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.
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Arm title
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GWP42004, 15 mg twice daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GWP42004
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Investigational medicinal product code |
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Other name |
Δ9-tetrahydrocannabivarin
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
GWP42004 was presented as a hard gelatin capsule containing 15 mg GWP42004 (Δ9-tetrahydrocannabivarin) and excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - FD&C blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.
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Arm title
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Placebo, twice daily | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Participants self-administered oral placebo in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical to GWP42004 treatment arms. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo was presented as a hard gelatin capsule containing excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - FD&C blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.
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Baseline characteristics reporting groups
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Reporting group title |
GWP42004, 2 mg twice daily
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Reporting group description |
Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GWP42004, 5 mg twice daily
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Reporting group description |
Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GWP42004, 15 mg twice daily
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Reporting group description |
Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo, twice daily
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Reporting group description |
Participants self-administered oral placebo in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical to GWP42004 treatment arms. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GWP42004, 2 mg twice daily
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Reporting group description |
Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||
Reporting group title |
GWP42004, 5 mg twice daily
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Reporting group description |
Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||
Reporting group title |
GWP42004, 15 mg twice daily
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Reporting group description |
Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | ||
Reporting group title |
Placebo, twice daily
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Reporting group description |
Participants self-administered oral placebo in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical to GWP42004 treatment arms. | ||
Subject analysis set title |
ITT Analysis Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The ITT analysis set included all randomized participants who took at least 1 dose of IMP and had post-baseline efficacy data.
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End point title |
Change From Baseline To The End Of Treatment In Mean Glycosylated Haemoglobin A1c (HbA1c) Level | ||||||||||||||||||||
End point description |
The change from baseline to the end of the 12-week treatment in mean HbA1c levels was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin.
Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. Baseline HbA1c was included as a covariate; dose, sex, and centre group were included as factors. Last visit using last observation carried forward (LOCF) was used where appropriate. If a participant in the ITT analysis set had no post-baseline HbA1c levels, baseline observation carried forward (BOCF) was used.
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End point type |
Primary
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End point timeframe |
Baseline, End of Treatment
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Statistical analysis title |
GWP42004, 2 mg twice daily versus Placebo | ||||||||||||||||||||
Comparison groups |
GWP42004, 2 mg twice daily v Placebo, twice daily
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.96 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-0.01
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.29 | ||||||||||||||||||||
upper limit |
0.28 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.14
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Statistical analysis title |
GWP42004, 5 mg twice daily versus Placebo | ||||||||||||||||||||
Comparison groups |
GWP42004, 5 mg twice daily v Placebo, twice daily
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Number of subjects included in analysis |
101
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.983 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.28 | ||||||||||||||||||||
upper limit |
0.28 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.14
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Statistical analysis title |
GWP42004, 15 mg twice daily versus Placebo | ||||||||||||||||||||
Comparison groups |
Placebo, twice daily v GWP42004, 15 mg twice daily
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Number of subjects included in analysis |
100
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||
P-value |
= 0.677 | ||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||
Parameter type |
Least square mean difference | ||||||||||||||||||||
Point estimate |
-0.06
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.34 | ||||||||||||||||||||
upper limit |
0.22 | ||||||||||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.14
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End point title |
Change From Baseline To The End Of Treatment In Mean Fasting Plasma Glucose Level | ||||||||||||||||||||
End point description |
The change from baseline to the end of the 12-week treatment in mean fasting plasma glucose levels was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin.
Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. Baseline fasting plasma glucose level was included as a covariate; dose, sex, and centre group were included as factors. Last visit using LOCF was used where appropriate.
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End point type |
Secondary
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End point timeframe |
Baseline, End of Treatment
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No statistical analyses for this end point |
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End point title |
Change From Baseline To The End Of Treatment In Mean Serum Fructosamine Levels | ||||||||||||||||||||
End point description |
The change from baseline to the end of the 12-week treatment in mean serum fructosamine levels was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin.
Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. Baseline serum fructosamine level was included as a covariate; dose, sex, and centre group were included as factors. Last visit using LOCF was used where appropriate.
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End point type |
Secondary
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End point timeframe |
Baseline, End of Treatment
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No statistical analyses for this end point |
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End point title |
Change From Baseline To The End Of Treatment In Mean Serum Glucose Levels In The Oral Glucose Tolerance Test [OGTT]) | ||||||||||||||||||||||||||||||
End point description |
The change from baseline to the end of the 12-week treatment in mean plasma glucose levels 30 minutes and 2 hours post glucose challenge using the OGTT was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin.
Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. The baseline value of the respective OGTT parameter was included as a covariate; dose, sex, and centre group were included as factors. Last visit using LOCF was used where appropriate.
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End point type |
Secondary
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End point timeframe |
Baseline, End of Treatment
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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 |
Screening (Visit 1, Day -7) up to the safety follow-up (Day 92)
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Adverse event reporting additional description |
An adverse event (AE) was any new, unintended symptom, diagnosis, or worsening of pre-existing condition presenting between screening and the safety follow-up call that may or may not be related to IMP, or any event that resulted from a trial procedure. Safety analysis set included randomized participants who received at least 1 dose of IMP.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
GWP42004, 2 mg twice daily
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Reporting group description |
Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GWP42004, 5 mg twice daily
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Reporting group description |
Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GWP42004, 15 mg twice daily
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Reporting group description |
Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo, twice daily
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Reporting group description |
Participants self-administered oral IMP placebo in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? No | |||
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 |