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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01562314
• Date of registration: 21/03/2012
• Prospective Registration: Yes
• Primary sponsor: GW Research Ltd
• Public title: A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)
• Scientific title: A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis
• Date of first enrolment: May 9, 2012
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01562314
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Czech Republic, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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;

- Received an Investigational Medicinal Product (IMP) within 30 days prior to the
screening visit;

- In the opinion of the investigator, was not considered to be suitable for the study;

- Any other significant disease or disorder which, in the opinion of the investigator,
may either have put the participant at risk because of participation in the study, or
may have influenced the result of the study or the participant's ability to
participate in the study;

- Participant with any abnormalities that, in the opinion of the investigator, would
prevent the participant from safe participation in the study;

- Unwilling to abstain from donation of blood during the study;

- Participants previously randomized into this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: GWP42003

Primary Outcome(s)

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)]

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]

Secondary Outcome(s)

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]

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]

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]

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

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]

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

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

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

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]

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

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

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

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

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

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]

Secondary ID(s)

GWID10160

2011-003208-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01562314