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A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)

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ClinicalTrials.gov Identifier: NCT01562314
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : August 14, 2015
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Drug: GWP42003
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GWP42003 GWP42003 was administered orally at a dose of 50 milligram (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.
Placebo 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.

Participant Flow:   Overall Study
    GWP42003   Placebo
STARTED   29   31 
Received at Least 1 Dose of Study Drug [1]   29   31 
Intent-to-Treat (ITT) Analysis Set [2]   29   31 
Per Protocol (PP) Analysis Set [3]   17   27 
COMPLETED   16   23 
NOT COMPLETED   13   8 
Adverse Event                10                5 
Met Withdrawal Criteria                3                2 
Withdrawal by Subject                0                1 
[1] Safety analysis set; participants analyzed according to treatment received.
[2] All randomized participants who received ≥1 dose of study drug; analyzed by randomization group.
[3] All participants without protocol violations that compromised the assessments of efficacy.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) analysis set: 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.

Reporting Groups
  Description
GWP42003 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.
Placebo 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.
Total Total of all reporting groups

Baseline Measures
   GWP42003   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   31   60 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.78  (15.050)   42.82  (12.916)   43.77  (13.903) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  20.7%      10  32.3%      16  26.7% 
Male      23  79.3%      21  67.7%      44  73.3% 


  Outcome Measures

1.  Primary:   Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT   [ Time Frame: Baseline to End of Treatment (EOT) (10 weeks) or Early Termination (ET) ]

2.  Primary:   Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

3.  Secondary:   Distribution On The PGAS At EOT   [ Time Frame: EOT (10 weeks) or ET ]

4.  Secondary:   Distribution On The PGAS At EOT - PP Analysis   [ Time Frame: EOT (10 weeks) or ET ]

5.  Secondary:   Change From Baseline To EOT In The PGAS Score   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

6.  Secondary:   Change From Baseline To EOT In The PGAS Score - PP Analysis   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

7.  Secondary:   Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

8.  Secondary:   Change From Baseline To EOT In The IBDQ Total Score - PP Analysis   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

9.  Secondary:   Number Of Participants Who Reported An Improvement In The Subject Global Impression Of Change (SGIC) Questionnaire At EOT   [ Time Frame: Visit 4 (Day 43) to EOT (10 weeks) or ET ]

10.  Secondary:   Number Of Participants Who Reported An Improvement In The SGIC Questionnaire At EOT - PP Analysis   [ Time Frame: Visit 4 (Day 43) to EOT (10 weeks) or ET ]

11.  Secondary:   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)   [ Time Frame: Baseline to EOT (last 7 days) or ET ]

12.  Secondary:   Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency NRS - PP Analysis   [ Time Frame: Baseline to EOT (last 7 days) or ET ]

13.  Secondary:   Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS   [ Time Frame: Baseline to EOT (last 7 days) or ET ]

14.  Secondary:   Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS - PP Analysis   [ Time Frame: Baseline to EOT (last 7 days) or ET ]

15.  Secondary:   Change From Baseline To EOT In The Mayo Total Score   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

16.  Secondary:   Change From Baseline To EOT In The Mayo Partial Score   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

17.  Secondary:   Change From Baseline To EOT In Levels Of Fecal Calprotectin   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

18.  Post-Hoc:   Change From Baseline To EOT In The Mayo Total Score - PP Analysis   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

19.  Post-Hoc:   Change From Baseline To EOT In The Mayo Partial Score - PP Analysis Set   [ Time Frame: Baseline to EOT (10 weeks) or ET ]

20.  Post-Hoc:   Change From Baseline To EOT In Levels Of Fecal Calprotectin- PP Analysis   [ Time Frame: Baseline to EOT (10 weeks) or ET ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Enquiries
Organization: GW Research Ltd
e-mail: medinfo@gwpharm.com, medinfo@greenwichbiosciences.com


Publications of Results:

Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT01562314     History of Changes
Other Study ID Numbers: GWID10160
2011-003208-19 ( EudraCT Number )
First Submitted: March 21, 2012
First Posted: March 23, 2012
Results First Submitted: June 22, 2015
Results First Posted: August 14, 2015
Last Update Posted: August 9, 2018