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: September 2, 2014
Last verified: September 2014
  Purpose

Ulcerative Colitis is an inflammatory bowel disease effecting large amounts of the population. The most common treatment for this condition is 5-ASA, however patients failing to respond to this and incurring a flare up are often escalated to steroidal treatments.

This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of GW42003 (0mg - 250mg twice daily), compared with placebo, by the percentage of participants achieving remission quantified as a MAYO score of 2 or less (with no subscore > 1) after 10 weeks treatment.

This is the first study to determine whether the study medication has a positive benefit for subjects on their ulcerative colitis symptom control, as well as effects on inflammatory marker cytokines (plasma TNFα, IL-2, IL-6), CRP, faecal inflammatory marker (calprotectin), stool frequency (NRS), rectal bleeding (NRS), pain (NRS). In addition, various IBD questionnaires are being implemented in the study to observe further benefits on the study medication, compared with placebo.

This study will be a multi-centre, randomised, double-blind, placebo-controlled, parallel-group pilot study. There will be two parallel groups of participants (0mg-250mg GWP42003 and placebo, twice daily), with a treatment duration of 10 weeks as well as a 7 day baseline period and one week follow-up. The two treatment groups of 0mg-250mg GWP42003 and placebo will be randomised equally into a 1:1 ratio, with 31 participants in the active IMP group and 31 participants allocated placebo treatment.

In order to be eligible for enrollment in this study, subjects will need to be aged 18 years and above (18-65 for Czech Republic) and be clinically diagnosed with with mild or moderate ulcerative colitis and on a fixed dose of 5-ASA treatment (0 mg dose of 5-ASA is acceptable) and have been on a stable dose for at least 2 weeks prior to screening.

Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline period. Each subject will have a MAYO (including endoscopy) assessment conducted to confirm eligibility. If eligible, the subject will be randomised into the 10-week treatment phase. There are a total of 6 visits in the study.


Condition Intervention Phase
Ulcerative Colitis
Drug: GWP42003
Drug: Placebo
Phase 2

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
Official Title: A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis.

Resource links provided by NLM:


Further study details as provided by GW Research Ltd:

Primary Outcome Measures:
  • To evaluate the efficacy of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a MAYO score of 2 or less (with no subscore>1). [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Efficacy Blood Sample Measurements [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ] [ Designated as safety issue: No ]
    Serum C-Reactive protein (CRP) Serum Cytokines (IL-6, IL-2 & TNF-α)

  • Clinical Efficacy Stool Sample Measurements [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ] [ Designated as safety issue: No ]
    Stool sample for faecal inflammatory marker calprotectin

  • Clinical Body Weight Assessment [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ] [ Designated as safety issue: No ]
    Body weight measurement

  • Clinical Assessments [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ] [ Designated as safety issue: No ]
    • IBDQ
    • SGIC
    • PGAS
    • MAYO Score

  • Ulcerative Colitis symptom measures [ Time Frame: Baseline to end of treatment (10 weeks treatment period) ] [ Designated as safety issue: No ]
    • Pain (NRS)
    • Rectal bleeding (NRS)
    • Stool frequency (NRS)


Enrollment: 60
Study Start Date: February 2012
Study Completion Date: August 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GWP42003
(0-250mg, BD)
Drug: GWP42003
1-5 capsules taken twice daily, 10 week treatment period.
Placebo Comparator: Placebo Drug: Placebo
1-5 capsules taken, twice daily. 10 week treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female participants aged 18 years or above (18-65 in the Czech Republic);
  • Participant diagnosed with mild to moderate ulcerative colitis and on a fixed dose of 5-ASA treatment and have been on a stable dose for at least 2 weeks prior to screening (0 mg dose of 5-ASA is acceptable);
  • Participants at screening (Visit 1) and baseline (Visit 2) 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 i.e. Proctitis
  • Gastrointestinal infection evident from stool culture and testing for clostridium difficile toxin (in the opinion of the investigator);
  • Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid based medications within one 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
    • hypersensitivity to cannabinoids;
  • Receiving a prohibited medication prior to screening (Visit 1) and for the duration of the study;
  • Previous non-responders to mono or polyclonal anti-Tumour 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 participant who is 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 two forms of contraception, one of which must be a barrier contraception (e.g. 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 be used in conjunction with the female condom);
  • Male participants whose partner is 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 (e.g. 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 be used in conjunction with a female condom);
  • Travel outside the country of residence planned 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, is not considered to be suitable for the study;
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or the participant's ability to participate in the study;
  • Following a physical examination, the participant has 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 randomised into this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562314

Locations
Czech Republic
Hepato-Gastroenterologie Hradec Králové
Hradec Králové, Czech Republic
Fakultní nemocnice Olomouc
Olomouc, Czech Republic
Fakultní nemocnice Plzeň
Plzeň, Czech Republic
Fakultní nemocnice v Motole
Praha, Czech Republic
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
University College London
London, United Kingdom
St Thomas' Hospital
London, United Kingdom
Northwick Park
London, United Kingdom
The Royal Free Hospital
London, United Kingdom
Wrightington Hospital
Wigan, United Kingdom
Sponsors and Collaborators
GW Research Ltd
Investigators
Study Chair: Peter Irving, MD St. Thomas' Hospital, London UK
Principal Investigator: Tariq Iqbal, MD Queen Elizabeth Hospital, Birmingham UK
Principal Investigator: Sreedhar Subramanian, MD Royal Liverpool Hospital UK
Principal Investigator: Chuka Nwokolo, MD University Hospital Coventry UK
Principal Investigator: Neeraj Prasad, MD Wrightington Hospital, Wigan UK
Principal Investigator: Stuart Bloom, MD University College London, London UK
Principal Investigator: Ailsa Hart, MD Northwick Park, London UK
Principal Investigator: Charles Murray, MD Royal Free Hosptial, London UK
Principal Investigator: Sean Weaver, MD Royal Bournemouth Hospital UK
Principal Investigator: Tariq Ahmad, MD Royal Devon & Exeter Hospital, Exeter UK
Principal Investigator: Radan Keil, MD Fakultní nemocnice v Motole, Praha, Czech Republic
Principal Investigator: Michal Konečný, MD Fakultní nemocnice Olomouc, Czech Republic
Principal Investigator: Jana Koželuhová, MD Fakultní nemocnice Plzeň, Czech Republic
Principal Investigator: Tomáš Vaňásek, MD Hepato-Gastroenterologie Hradec Králové, Czech Republic
  More Information

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
Last Updated: September 2, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control

Keywords provided by GW Research Ltd:
Mild to Moderate Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on October 01, 2014