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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd
ClinicalTrials.gov Identifier:
NCT01562314
First received: March 21, 2012
Last updated: July 17, 2015
Last verified: June 2015
Results First Received: June 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ulcerative Colitis
Interventions: Drug: GWP42003
Drug: Placebo

  Participant Flow
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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

(0-250mg, BD)

GWP42003: 1-5 capsules taken twice daily; 10 week treatment period.

Placebo Placebo: 1-5 capsules taken twice daily; 10 week treatment period.

Participant Flow:   Overall Study
    GWP42003     Placebo  
STARTED     29     31  
COMPLETED     16     23  
NOT COMPLETED     13     8  
Adverse Event                 10                 5  
Met Withdrawal Criteria                 3                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
GWP42003

(0-250mg, BD)

GWP42003: 1-5 capsules taken twice daily; 10 week treatment period.

Placebo Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
Total Total of all reporting groups

Baseline Measures
    GWP42003     Placebo     Total  
Number of Participants  
[units: participants]
  29     31     60  
Age  
[units: years]
Mean (Standard Deviation)
  44.78  (15.050)     42.82  (12.916)     43.77  (13.903)  
Gender  
[units: participants]
     
Female     6     10     16  
Male     23     21     44  
Race/Ethnicity, Customized  
[units: participants]
     
White/Caucasian     21     22     43  
Black/African American     1     0     1  
Asian     6     6     12  
Other     1     3     4  
Region of Enrollment  
[units: participants]
     
United Kingdom     29     31     60  
Previous cannabis use (at any time including last year)  
[units: participants]
  9     4     13  
Time since last cannabis use  
[units: years]
Mean (Standard Deviation)
  13.80  (10.681)     9.99  (11.344)     12.53  (10.546)  
Height  
[units: cm]
Mean (Standard Deviation)
  173.04  (9.423)     169.39  (9.491)     171.15  (9.557)  
Weight  
[units: Kg]
Mean (Standard Deviation)
     
Male     85.01  (18.693)     74.27  (9.471)     79.88  (15.809)  
Female     71.57  (23.743)     74.03  (21.171)     73.11  (21.409)  
BMI  
[units: Kg/m2]
Mean (Standard Deviation)
  27.29  (5.783)     25.98  (5.241)     26.62  (5.502)  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Remission, Quantified as a Mayo Score of 2 or Less (With no Sub-score >1).   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

2.  Primary:   Percentage of Participants Achieving Remission Quantified as a Mayo Score of 2 or Less (With no Sub-score >1) - PP Analysis Set   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

3.  Secondary:   Clinical Efficacy Blood Sample Measurements - C Reactive Protein (CRP)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

4.  Secondary:   Clinical Efficacy Blood Sample Measurements - Interleukin (IL)-2   [ Time Frame: Baseline to end of treatment (10 week treatment period) ]

5.  Secondary:   Clinical Efficacy Blood Sample Measurements - IL-6   [ Time Frame: Baseline to end of treatment (10 week treatment period) ]

6.  Secondary:   Clinical Efficacy Blood Sample Measurements - Tumour Necrosis Factor (TNF)   [ Time Frame: Baseline to end of treatment (10 week treatment period) ]

7.  Secondary:   Clinical Efficacy Stool Sample Measurements   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

8.  Secondary:   Clinical Assessments - Inflammatory Bowel Disease Questionnaire (IBDQ)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

9.  Secondary:   Clinical Assessments - IBDQ - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

10.  Secondary:   Clinical Assessments - Subject Global Impression of Change (SGIC)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

11.  Secondary:   Clinical Assessments - SGIC - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

12.  Secondary:   Clinical Assessments - Physician's Global Assessment of Illness Severity (PGAS)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

13.  Secondary:   Clinical Assessments - PGAS - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

14.  Secondary:   Ulcerative Colitis Symptom Measures - Pain   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

15.  Secondary:   Ulcerative Colitis Symptom Measures - Stool Frequency   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

16.  Secondary:   Ulcerative Colitis Symptom Measures - Stool Frequency - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

17.  Secondary:   Ulcerative Colitis Symptom Measures - Rectal Bleeding   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

18.  Secondary:   Ulcerative Colitis Symptom Measures - Rectal Bleeding - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

19.  Secondary:   Plasma Endocannabinoid Levels - 2-arachidonoyl Glycerol (2-AG)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

20.  Secondary:   Plasma Endocannabinoid Levels - Anandamide (AEA)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

21.  Secondary:   Plasma Endocannabinoid Levels - Oleoylethanolamide (OEA)   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

22.  Secondary:   Plasma Endocannabinoid Levels - PEA   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

23.  Secondary:   Mayo Total Score   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

24.  Secondary:   Mayo Partial Score   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

25.  Secondary:   Mayo Score: Responder Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

26.  Secondary:   Clinical Body Weight Assessment   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

27.  Post-Hoc:   Clinical Efficacy Blood Sample Measurements - CRP - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

28.  Post-Hoc:   Clinical Efficacy Blood Sample Measurements - IL-2 - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

29.  Post-Hoc:   Clinical Efficacy Blood Sample Measurements - IL-6 - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

30.  Post-Hoc:   Clinical Efficacy Blood Sample Measurements - TNF - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

31.  Post-Hoc:   Clinical Efficacy Stool Sample Measurements - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

32.  Post-Hoc:   Ulcerative Colitis Symptom Measures - Pain - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

33.  Post-Hoc:   Mayo Total Score - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

34.  Post-Hoc:   Mayo Score: Responder Analysis - PP Analysis   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]

35.  Post-Hoc:   Mayo Partial Score - PP Analysis Set   [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Clinical Operations Director
Organization: GW Research Ltd.
phone: +44 (0)1980 557000
e-mail: rp@gwpharm.com


No publications provided


Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT01562314     History of Changes
Other Study ID Numbers: GWID10160
Study First Received: March 21, 2012
Results First Received: June 22, 2015
Last Updated: July 17, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control