A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)
A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis
2 other identifiers
interventional
60
1 country
8
Brief Summary
This study was conducted to determine the efficacy and safety 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 of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedStudy Start
First participant enrolled
May 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2014
CompletedResults Posted
Study results publicly available
August 14, 2015
CompletedAugust 9, 2018
July 1, 2018
2.2 years
March 21, 2012
June 22, 2015
July 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT
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); Physician's Global Assessment of Illness Severity (PGAS): 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Baseline to End of Treatment (EOT) (10 weeks) or Early Termination (ET)
Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis
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.
Baseline to EOT (10 weeks) or ET
Secondary Outcomes (15)
Distribution On The PGAS At EOT
EOT (10 weeks) or ET
Distribution On The PGAS At EOT - PP Analysis
EOT (10 weeks) or ET
Change From Baseline To EOT In The PGAS Score
Baseline to EOT (10 weeks) or ET
Change From Baseline To EOT In The PGAS Score - PP Analysis
Baseline to EOT (10 weeks) or ET
Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Baseline to EOT (10 weeks) or ET
- +10 more secondary outcomes
Study Arms (2)
GWP42003
EXPERIMENTALGWP42003 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 COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female participants aged 18 years or above;
- Participant diagnosed with mild to moderate ulcerative colitis and on a fixed dose of 5-Aminosalicylic (5-ASA) treatment and have been on a stable dose for at least 2 weeks prior to screening (0 mg dose of 5-ASA was acceptable);
- Participants at screening and baseline with a Mayo assessment score of greater than or equal to 4 (≥4) but less than or equal to 10 (≤10) and with an endoscopy score of at least 1 (≥1) , following an adequate exposure to oral and/ or topical 5-ASA, in the opinion of the investigator;
- In the opinion of the investigator, capable of complying with the study requirements and completing the study;
- Willing and able to give informed consent;
- Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable;
- Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study;
You may not qualify if:
- Severe ulcerative colitis (Mayo score of greater than 10 (\>10);
- Ulcerative colitis only affecting the rectum (proctitis)
- Gastrointestinal infection evident from stool culture and testing for Clostridium difficile toxin (in the opinion of the investigator);
- Currently using or had used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid-based medications within 1 month prior to study entry and unwilling to abstain for the duration of the study;
- Any known or suspected history of alcohol or substance abuse, epilepsy or recurrent seizures, or hypersensitivity to cannabinoids;
- Was receiving a prohibited medication prior to screening and for the duration of the study;
- Previous non-responders to mono or polyclonal anti-Tumor Necrosis Factor antibodies;
- Personal or first degree relative, with history of schizophrenia or other psychosis;
- History of other significant psychiatric disorder or severe personality disorder (at the discretion of the investigator);
- Any known or suspected history of depression sufficient to require treatment with antidepressants or disrupt ordinary life (excluding episodes of reactive depression at the discretion of the investigator);
- Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator;
- Female participants who were pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose;
- Female participants of child bearing potential, unless willing to use 2 forms of contraception, 1 of which must have been a barrier contraception (for example, a female condom or occlusive cap \[diaphragm or cervical vault/caps\] with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not have been used in conjunction with the female condom);
- Male participants whose partner was of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (for example, an occlusive cap \[diaphragm or cervical vault/caps\] with spermicide) during the study and for 3 months from date of last dose (however a male condom should not have been used in conjunction with a female condom);
- Planned to travel outside the country of residence during the treatment phase of the study;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GW Research Ltdlead
Study Sites (8)
Unknown Facility
Birmingham, B15 2TH, United Kingdom
Unknown Facility
Coventry, CV2 2DX, United Kingdom
Unknown Facility
Liverpool, L7 8XP, United Kingdom
Unknown Facility
London, NW1 2PG, United Kingdom
Unknown Facility
London, NW3 2QG, United Kingdom
Unknown Facility
London, SE1 7EH, United Kingdom
Unknown Facility
Middlesex, HA1 3UJ, United Kingdom
Unknown Facility
Wigan, WN1 2NN, United Kingdom
Related Publications (1)
Irving PM, Iqbal T, Nwokolo C, Subramanian S, Bloom S, Prasad N, Hart A, Murray C, Lindsay JO, Taylor A, Barron R, Wright S. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis. Inflamm Bowel Dis. 2018 Mar 19;24(4):714-724. doi: 10.1093/ibd/izy002.
PMID: 29538683RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Enquiries
- Organization
- GW Research Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2012
First Posted
March 23, 2012
Study Start
May 9, 2012
Primary Completion
August 5, 2014
Study Completion
August 5, 2014
Last Updated
August 9, 2018
Results First Posted
August 14, 2015
Record last verified: 2018-07