Clinical Trial Results:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once Daily for 14 Days to Patients with Functional Dyspepsia
|
Summary
|
|
EudraCT number |
2012-002748-25 |
Trial protocol |
NL BE |
Global end of trial date |
25 Jan 2014
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
10 Mar 2021
|
First version publication date |
10 Mar 2021
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
ICP-112-201
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01712412 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Ironwood Pharmaceuticals Inc.
|
||
Sponsor organisation address |
100 Summer Street Suite 2300, Boston, MA, United States, 02110
|
||
Public contact |
Corporate Communications, Ironwood Pharmaceuticals Inc., +1 6176217722, Info@ironwoodpharma.com
|
||
Scientific contact |
Corporate Communications, Ironwood Pharmaceuticals Inc., +1 6176217722, Info@ironwoodpharma.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Jan 2014
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
25 Jan 2014
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The objectives of the study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia, with and without concomitant proton pump inhibitor and/or H2 receptor antagonist (H2RA) administration.
|
||
Protection of trial subjects |
The Screening Period began with the signature of the informed consent form (ICF) at the Screening Visit (which occurred between Day -59 and Day -18).
|
||
Background therapy |
Subjects who entered the study on a proton pump inhibitor (PPI) and/or H2 receptor antagonist (H2RA) must have continued the use of those agents without any changes to the dose or frequency throughout the Screening, Pretreatment, Treatment, and Post-treatment Periods. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Nov 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belgium: 5
|
||
Country: Number of subjects enrolled |
Netherlands: 5
|
||
Worldwide total number of subjects |
10
|
||
EEA total number of subjects |
10
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
10
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||||||||
|
Recruitment
|
||||||||||||||||
Recruitment details |
- | |||||||||||||||
|
Pre-assignment
|
||||||||||||||||
Screening details |
The Screening Period may have lasted up to 42 days. Subjects who met the Rome III criteria for functional dyspepsia (FD) and met all Screening criteria proceeded to the Pretreatment Period. The Pretreatment Period occurred immediately after the Screening Period and consisted of the 14 to 17 days immediately prior to the Randomization Visit. | |||||||||||||||
|
Period 1
|
||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
|||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||
Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator, Data analyst | |||||||||||||||
Blinding implementation details |
Randomization was performed using a computer-generated randomization scheme. The subjects, the investigators, and the sponsor were blinded to the treatment assignments until after the study completion and database lock.
|
|||||||||||||||
|
Arms
|
||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||
|
Arm title
|
Placebo | |||||||||||||||
Arm description |
Oral placebo once daily (QD) for 14 days | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
placebo
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Capsule
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
At the Randomization Visit, subjects underwent a meal challenge test consisting of pre-meal symptom measurements and a standardized meal followed by post-meal symptom measurements. The first dose of investigational medicinal product (IMP) was taken at the Randomization Visit after the meal challenge test. Daily administration of IMP continued for a total of 14 days through the End-of-Treatment (EOT) Visit. Subjects repeated the meal challenge test at the EOT Visit receiving the last dose of IMP at the study center during the EOT Visit, just prior to the meal challenge test. Subjects who did not undergo the meal challenge received their first does of IMP at the Randomization Visit and followed the same dosing schedule as those who underwent the meal challenge test.
|
|||||||||||||||
|
Arm title
|
IW-9179 500 µg | |||||||||||||||
Arm description |
IW-9179 500 µg QD for 14 days | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
IW-9179
|
|||||||||||||||
Investigational medicinal product code |
||||||||||||||||
Other name |
||||||||||||||||
Pharmaceutical forms |
Capsule
|
|||||||||||||||
Routes of administration |
Oral use
|
|||||||||||||||
Dosage and administration details |
At the Randomization Visit, subjects underwent a meal challenge test consisting of pre-meal symptom measurements and a standardized meal followed by post-meal symptom measurements. The first dose of IMP was taken at the Randomization Visit after the meal challenge test. Daily administration of IMP continued for a total of 14 days through the EOT Visit. Subjects repeated the meal challenge test at the EOT Visit receiving the last dose of IMP at the study center during the EOT Visit, just prior to the meal challenge test. Subjects who did not undergo the meal challenge received their first does of IMP at the Randomization Visit and followed the same dosing schedule as those who underwent the meal challenge test.
|
|||||||||||||||
|
||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Oral placebo once daily (QD) for 14 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IW-9179 500 µg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
IW-9179 500 µg QD for 14 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Placebo
|
||
Reporting group description |
Oral placebo once daily (QD) for 14 days | ||
Reporting group title |
IW-9179 500 µg
|
||
Reporting group description |
IW-9179 500 µg QD for 14 days | ||
|
|||||||||||||
End point title |
Change From Baseline in Daily Patient Symptom Severity (PSS) Assessment During the Treatment Period: Postprandial Fullness [1] | ||||||||||||
End point description |
PSS assessments were collected daily for the following 11 symptoms: epigastric pain, epigastric burning,epigastric bloating, postprandial fullness, early satiation, nausea, belching, heartburn, regurgitation,nonepigastric pain, and nonepigastric bloating. Subjects assessed the severity of these symptoms (with the exception of early satiation) on an 11-point (0-10) NRS, where 0 = none and 10 = very severe.Early satiation was assessed on a 5-point ordinal scale (none, mild, moderate, severe, and very severe). For each of the daily-assessed symptoms, the PSS for a specified period is the average of the non-missing scores over the treatment period.
Postprandial Fullness
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline, up to Day 14
|
||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive statistics are presented as per the protocol. The study was not powered to detect a statistically significant difference. The other 10 symptom included in the Daily PSS Assessment, are reported out under "Secondary Endpoints". |
|||||||||||||
|
|||||||||||||
| Notes [2] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [3] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in Average Post-Meal Symptom Severity (PMSSD) Assessment at EOT (Day 14) | |||||||||||||||||||||||||||||||||
End point description |
The PMSS assesses the following 7 symptoms: epigastric pain, epigastric burning, epigastric bloating, nausea, belching, heartburn, and regurgitation. Subjects assess the severity of these meal symptoms on an 11-point (0-10) numerical rating scale (NRS), where 0 = none and 10 = very severe. The average PMSSD is obtained by averaging the PMSSDs across all post-meal time points. For each post-meal symptom, change from baseline (Day 1) to the EOT Visit (Day 14) in the average PMSSD was summarized.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, EOT (Day 14): assessments are collected 15 minutes before the meal (t= -15 minutes), just prior to beginning to eat the meal (t=0 minutes), and then every 15 minutes after the meal for the next 4 hours.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
| Notes [4] - Intent-to-Treat Population: Randomized subjects with a baseline and EOT assessment. [5] - Intent-to-Treat Population: Randomized subjects with a baseline and EOT assessment. |
||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in Daily Patient Symptom Severity (PSS) Assessment During the Treatment Period | ||||||||||||||||||||||||||||||||||||||||||
End point description |
PSS assessments were collected daily for the following 11 symptoms: epigastric pain, epigastric burning, epigastric bloating, postprandial fullness, early satiation, nausea, belching, heartburn, regurgitation, nonepigastric pain, and nonepigastric bloating. Subjects assessed the severity of these symptoms (with the exception of early satiation) on an 11-point (0-10) NRS, where 0 = none and 10 = very severe. Early satiation was assessed on a 5-point ordinal scale (none, mild, moderate, severe, and very severe). For each of the daily-assessed symptoms, the PSS for a specified period is the average of the non-missing scores over the treatment period.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, up to Day 14
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
| Notes [6] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [7] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Who Were Weekly Symptom Relief (SR) Assessment Responders at Day 7 and Day 14 | |||||||||||||||||||||||||||
End point description |
Weekly SR assessments were collected on Day 7 and Day 14 of the Treatment Period. Subjects assessed their degree of relief of dyspepsia symptoms, early satiation, postprandial fullness, epigastric pain, and epigastric burning during the previous week on a 7-point balanced scale (completely relieved, considerably relieved, somewhat relieved, unchanged, somewhat worse, considerably worse, and as bad as I can imagine). For each of the 5 symptoms assessed weekly for degree of relief, an SR Responder was a subject who reported “somewhat relieved”, “considerably relieved”, or “completely relieved” for both weeks of the Treatment Period.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Collected on Day 7 and Day 14 of the Treatment Period
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Notes [8] - Intent-to-Treat Population: randomized subjects with an assessment at Days 7 and 14. [9] - Intent-to-Treat Population: randomized subjects with an assessment at Days 7 and 14. |
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change From Baseline in Nepean Dyspepsia Index (NDI) Questionnaire at EOT (Day 14) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Subjects completed the Nepean Dyspepsia Index (NDI) questionnaire to indicate the frequency (using a 0 [not at all] to 4 [every day/almost every day] ordinal scale), intensity (using a 0 [not at all] to 5 [very severe] ordinal scale), and bothersomeness (using a 0 [not at all] to 4 [extremely] ordinal scale) of 15 stomach problems they'd had in the last two weeks. For each stomach problem, an NDI symptom score was derived by adding the scores for frequency, intensity, and bothersomeness, for a total score range of 0 to 13 for each stomach problem, with higher scores indicating a worse problems.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline, EOT (Day 14)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [10] - Intent-to-Treat Population: Randomized subjects with a baseline and EOT assessment. [11] - Intent-to-Treat Population: Randomized subjects with a baseline and EOT assessment. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Change From Baseline in Weekly Rate of Bowel Movements (BMs) During the Treatment Period | ||||||||||||
End point description |
BM data were collected daily. A CBM is a BM that is associated with a sense of complete evacuation.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, End of Treatment (up to Day 14)
|
||||||||||||
|
|||||||||||||
| Notes [12] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [13] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change From Baseline in Weekly Rate of Complete Bowel Movements (CBMs) During the Treatment Period | ||||||||||||
End point description |
BM data were collected daily. A CBM is a BM that is associated with a sense of complete evacuation.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, End of Treatment (up to Day 14)
|
||||||||||||
|
|||||||||||||
| Notes [14] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [15] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change From Baseline in Weekly Rate of Spontaneous Bowel Movements (SBMs) During the Treatment Period | ||||||||||||
End point description |
BM data were collected daily. An SBM is a BM that occurs in the absence of laxative, suppository, or enema use. For analysis purposes, BMs occurring within 24 hours of laxative, suppository, or enema use were not considered SBMs.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, End of Treatment (up to Day 14)
|
||||||||||||
|
|||||||||||||
| Notes [16] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [17] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change From Baseline in Weekly Rate of Complete Spontaneous Bowel Movements (CSBMs) During the Treatment Period | ||||||||||||
End point description |
BM data were collected daily. A CSBM is an SBM that is associated with a sense of complete evacuation. An SBM is a BM that occurs in the absence of laxative, suppository, or enema use. For analysis purposes, BMs occurring within 24 hours of laxative, suppository, or enema use were not considered SBMs.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, End of Treatment (up to Day 14)
|
||||||||||||
|
|||||||||||||
| Notes [18] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [19] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change From Baseline in Stool Consistency, as Measured by the Bristol Stool Form Scale During the Treatment Period | ||||||||||||
End point description |
Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, End of Treatment (up to Day 14)
|
||||||||||||
|
|||||||||||||
| Notes [20] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. [21] - Intent to Treat Population: randomized subjects with a baseline and post-baseline assessment. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From the Randomization Visit (Day 1) through the End-of-Study Visit (Day 22 +3 days).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
matching oral placebo once daily (QD) for 14 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
IW-9179 500 µg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
IW-9179 500 µg QD for 14 days | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
25 Apr 2013 |
The following changes were made to the protocol to allow for a more inclusive patient population:
• Treatment group randomization will no longer be stratified on whether or not a patient is currently taking a proton pump inhibitor (PPI) at the time of the Screening Visit. Stratification will now be based on whether or not a patient is currently taking a PPI and/or a H2 receptor agonist (H2RA) at the time of the Pretreatment Visit.
• Inclusion #5 was modified to remove the Rome III criteria Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome (EPS) subgroup eligibility requirements. It now includes only the Rome III criteria for functional dyspepsia eligibility requirement.
• Inclusion #7 was edited to simplify the “worst postprandial fullness” eligibility requirement.
• Inclusion #8 now allows concomitant use of H2RA without any changes to the dose or frequency throughout the duration of the study.
• Exclusion #1 was revised to add an average daily score for heartburn to the eligibility requirement.
• Exclusion #s 8, 9, 10, and 22 were removed.
• Exclusion #9 was revised to no longer require IgA and tTg testing. Patients are now excluded if diagnosed with, or suspected of having celiac disease.
• Exclusion #20 was modified to allow patients who previously entered the pretreatment period to rescreen based on specific criteria and at the discretion of the Medical Monitor.
Other changes made to the protocol can be summarized as follows:
• The Screening Period was increased from 28 to 42 days to accommodate the scheduling of esophagogastroduodenoscopies.
• Medical history will now include specific details regarding the patient’s most recent test for H. pylori (if applicable) at Screening and if antibiotic treatment was given in order to collect information on whether previous H. pylori infection affects treatment response. |
||
25 Apr 2013 |
(continued)
• The serum alcohol test was moved from the Randomization Visit to the Pretreatment Visit in order to obtain the results prior to Randomization.
• The Meal Challenge Test may be waived after discussion with the Medical Monitor if the patient prefers not to complete it. Patients that do not complete the Meal Challenge Test at the Randomization Visit will not undergo this test at the End-of-treatment Visit. This option was included due to the time commitment involved with performing the procedure.
• Benzodiazepenes were added to the Prohibited Medications list (Appendix 1) due to their potential effects on endpoint measurements and usual use in a non-stable dosing regiment (i.e. “as needed” use).
• Updated the Medical Monitor and associated contact details due to a change in staffing.
• Minor administrative changes were made that do not affect the conduct of the study. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
