Pain Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of-Concept Study of GIC-1001 for the Management of Visceral Pain in Subjects Undergoing Sedation-Free, Full Colonoscopy
NCT number | NCT01926444 |
Other study ID # | GIC13-01 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 2013 |
Est. completion date | March 2014 |
Verified date | May 2019 |
Source | gicare Pharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative to i.v. sedation during full colonoscopy. It will be evaluated for efficacy and safety in a multi-center, randomized, double-blind, placebo controlled, dose-ranging, proof of concept Phase 2a trial. Up to 240 patients will receive one of 3 doses of GIC-1001 or its matching placebo. A pharmacokinetic evaluation will be carried out on a subset of patients (N: 24).
Status | Completed |
Enrollment | 308 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Signed and dated written Informed Consent obtained. 2. Males or females. 3. Aged 40-75 years. 4. Indication for full colonoscopy for colorectal cancer screening or investigation, including subjects presenting suggestive symptoms and who need a differential diagnosis. 5. Colonoscopy naïve subjects, i.e. who never underwent colonoscopy before, will be eligible, as well as non-naïve subjects who have previously undergone unsedated colonoscopy , or who had sedated colonoscopy at least 10 years prior (i.e. = 10 years) to enrolment 6. Eligible for a procedure without sedation. 7. Able to complete questionnaires and use a Visual Analog Scale (VAS), including sufficient English, French or Spanish speaking skills as well as adequate eyesight and hearing 8. BMI = 19, BMI = 40 kg/m2. Exclusion Criteria: 1. Known allergy or intolerance to trimebutine (Modulon® or generic). 2. Known allergy or intolerance to sulfur-containing drugs (e.g. N-acetylcysteine or captopril). 3. Previous gastrointestinal or gynecologic surgery, e.g. ileostomy, pelvic surgery,; however, patients with an appendectomy are eligible.Patients who have had a tubal ligation at least 10 years prior (i.e. = 10 years) to enrolment are also eligible. 4. Diagnosed Inflammatory Bowel Disease (IBD). 5. Visceral hypersensitivity conditions such as Irritable Bowel Syndrome (IBS). 6. Clinically significant renal and/or hepatic impairment. 7. History of peritonitis. 8. Known severe diverticular disease. 9. Severe diverticulosis as documented by prior imaging series 10. Known or suspected stenosis of the colon. 11. Chronic pain syndrome such as fibromyalgia and endometriosis. 12. Any clinically-relevant abnormality identified on the screening, history, physical examination, 12-lead ECG or laboratory examination, which would, in the Investigator's opinion, preclude the administration of investigational drug product, GIC1001 13. Unexpected and significant visceral pain reported by subject prior to colonoscopy. 14. Dementia. 15. Diagnosed clinically significant psychiatric illness, including severe anxiety disorders that may affect the subject's perception of visceral pain or ability to participate in the study. 16. Patient is a lactating female. 17. Female is of childbearing potential sexually active who are unwilling or unable to use an acceptable method of contraception (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or sterile sexual partner) throughout the duration of the study and 1 month following study completion. 18. Female is of childbearing potential, sexually abstinent who does not agree to continue abstinence or to use one of the acceptable methods of birth control should sexual activity commence. 19. Any serious medical condition that could increase the risk of adverse reactions with trimebutine. 20. Participation in another experimental drug trial within 30 days of randomization. |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique 1037 | Montreal | Quebec |
Canada | Spécialistes MD Specialists | Montreal | Quebec |
Canada | Toronto Digestive Disease Associates | Toronto | Ontario |
Canada | GIRI (GI Research Institute) | Vancouver | British Columbia |
United States | Anaheim Clinical Trials | Anaheim | California |
United States | Montefiore Medical Center | Bronx | New York |
United States | Precision Research Institute | Chula Vista | California |
United States | Avail Clinical Research LLC | DeLand | Florida |
United States | PharmaTrials | Hillsborough | New Jersey |
United States | Mid-Atlantic Medical Research Centers | Hollywood | Maryland |
United States | The Center for GI Disorders | Hollywood | Florida |
United States | Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | Precision Research Institute | San Diego | California |
United States | Mayo Clinic | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
gicare Pharma Inc. | Algorithme Pharma Inc, JSS Medical Research Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS) | The Primary Outcomes Measure was the pain VAS 100-mm AUC (0mm = no pain; 100mm = worst pain), constructed from serial pain VAS measurements performed during colonoscopy. At least 8 pain VAS measurements were made, and the length of the colonoscope inserted (or removed on the way out) was recorded at every measurement. The X-axis of the VAS versus anatomical locations was defined accordingly: each VAS value corresponded to a relative length of inserted colonoscope (d/2Lc) of the X axis, where d was the actual length of the inserted colonoscope and 2Lc represented twice the total length of the colon examined (Lc). Before scope insertion the X value equaled zero. Once the caecum was reached, the X value was 0.5. Upon complete removal of the endoscope, the X value was 1. This allowed standardization of colonic length between study subjects. Visceral pain AUC (mm) was calculated from all serial measurements, where the length of inserted colonoscope determined the VAS measurement's location | Assessed at different anatomical locations: (1) before colonoscopy, (2) insertion of scope in anus, (3) at rectosigmoid flexure, (4) at splenic flexure, (5) at hepatic flexure, (6) at caecum, (7) at splenic flexure on way back, (8) after colonoscopy. | |
Secondary | Time to Caecum | Time to Caecum is the time taken by the physician to reach the caecum with the colonoscope, from the insertion in the anus. Time to Caecum was measured during colonoscopy, for which total duration of colonoscopy ranged between a minimum of 5.00 and a maximum of 50.10 minutes. | From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes. | |
Secondary | Colonoscopy Completion Rate (%) | Qualitative outcome: colonoscopy completion is defined as a procedure performed entirely, from initial anal insertion, reaching of caecum, and complete removal of the scope. Completion rate is then the number of patient (%) with a complete colonoscopy (up to the caecum) divided by the number of trial participants. | Number of patients during trial with a complete colonoscopy, where the scope has reached the caecum during the colonoscopy. Range of duration of colonoscopy 5.00- 50.10 minutes. | |
Secondary | Safety-Plasma Concentrations of Trimebutine and N-Desmethyl-Trimebutine | A pharmacokinetic (PK) analysis was carried out on the first 24 patients randomized, equally distributed between treatment groups; 18 patients were assigned to active treatment | Day 4 prior to colonoscopy. | |
Secondary | Total Examination Time (Colonoscopy) | Defined as the time from endoscope insertion to complete removal of the endoscope; measured in minutes | From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes. | |
Secondary | Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal | Endoscopist's perception of the adequacy of analgesia, difficulty of insertion and withdrawal measured on a five-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree | From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes. | |
Secondary | Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal | Endoscopist's perception of the amount of colonic spasm on insertion and withdrawal measured on five-point Likert scale according to the following: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree | From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes. | |
Secondary | Patient's Willingness to Repeat Experience | Patients' willingness for repeat colonoscopy, was assessed with the Patient Willingness to Repeat Experience (P.W.R.E.) questionnaire (1 question), asking patients to rate their willingness to repeat the procedure according to a 5-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree. The P.W.R.E was administered after the colonoscopy during subject recovery. | Post-colonoscopy- during subject recovery | |
Secondary | Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain | Subject satisfaction and acceptability of the colonic analgesia modality offered by GIC-1001 was assessed with the Patient Global Impression of Abdominal Pain (P.G.I.A.P.) (1 question), asking patients to rate their pain during the procedure according to a 5-point Likert scale: Absent, Mild, Moderate, Severe, Intolerable. The P.G.I.A.P was administered after the colonoscopy during subject recovery. | Post-colonoscopy- during subject recovery |
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