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A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy

Primary Purpose

Pain, Cancer, Colonic Diseases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GIC-1001
Sponsored by
gicare Pharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring colonoscopy, sedation-free, colorectal cancer, CRC screening, prevention, analgesia, colonic, kappa, opioid agonist, pain management, oral, hydrogen sulfide, peripheral

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic
  • Anaheim Clinical Trials
  • Precision Research Institute
  • Precision Research Institute
  • Avail Clinical Research LLC
  • The Center for GI Disorders
  • Mid-Atlantic Medical Research Centers
  • Mayo Clinic Rochester
  • PharmaTrials
  • Montefiore Medical Center
  • Gastroenterology Associates of Orangeburg
  • GIRI (GI Research Institute)
  • Toronto Digestive Disease Associates
  • Clinique 1037
  • Spécialistes MD Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

GIC-1001 low dose

GIC-1001 mid-dose

GIC-1001 , high dose

GIC-1001 matching placebo

Arm Description

GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)

GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)

GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)

Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
Total Examination Time (Colonoscopy)
Defined as the time from endoscope insertion to complete removal of the endoscope; measured in minutes
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
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
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.
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.

Full Information

First Posted
August 8, 2013
Last Updated
May 6, 2019
Sponsor
gicare Pharma Inc.
Collaborators
JSS Medical Research Inc., Algorithme Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01926444
Brief Title
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
gicare Pharma Inc.
Collaborators
JSS Medical Research Inc., Algorithme Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
Study Objectives 1.1 Primary objective: The primary objective of this Phase IIa study is to establish clinical Proof-of-Concept (POC) by providing clinically and statistically significant evidence that GIC-1001 is safe and effective in managing visceral pain in male and female patients who undergo sedation-free, full colonoscopy for preventive purposes. 1.2 Secondary objectives: Secondary objectives will include the selection of the optimal dose of GIC-1001 from a safety/efficacy ratio point of view, establish a preliminary safety profile of the drug in patients, and obtain a preliminary general efficacy profile of GIC-1001 by assessing various secondary endpoints Study Endpoints 2.1 Primary endpoints: Visceral pain will be assessed using a 100-mm VAS, measured at various times and anatomical segments (N: 8) throughout the colon, i.e.: Prior to intra-rectal insertion of the endoscope; After insertion through the anus; After passage through the rectosigmoid segment; Immediately after passage through the splenic flexure; Immediately after passage through the hepatic flexure; Once the caecum is reached; Immediately after passage through the splenic flexure during scope withdrawal; and At the end of the procedure, once the colonoscope has been completely removed. Any additional episodes of pain experienced by the patient will also be assessed using the 100-mm VAS scale. The area under the curve (AUC) calculated from all serial measurements made will be used for statistical purposes, where the length of inserted colonoscope determines the VAS measurement's location. 2.2 Secondary endpoints: Overall pain perception (100-mm VAS) at the end of the procedure; Time to reach the caecum with the endoscope (intubation time from rectum to caecum defined as time-to-caecum); Total examination time, defined at the time from introduction to removal of the colonoscope; Percentage of completed procedures; Endoscopist's perception of the adequacy of analgesia, difficulty of insertion, and amount of colonic spasm on insertion and withdrawal (five-point Likert scale); Use of rescue sedation (i.e. midazolam or midazolam followed by fentanyl) Safety as assessed by the incidence of treatment emergent adverse effects during the procedure and for 30 days after; Plasma determination of trimebutine and N-desmethyl-trimebutine moieties at GIC-1001 plasmatic steady state; Patient satisfaction with treatment (five-point Likert scale); Patient' willingness for repeat colonoscopy in the future (five-point Likert scale); and Safety of GIC-1001. Study Design This is a randomized, double-blind, placebo-controlled parallel design 4-treatment arms study. Eligible patients will be randomized in a 1:1:1:2 ratio to one of 4 treatment arms: low (250 mg), mid (375 mg) or high (500 mg) dose of GIC-1001, or matching placebo. All potential study subjects will be screened and assessed for eligibility within maximum two (2) weeks prior to randomization. Bowel preparation will be performed using a polyethylene glycol (PEG) based regimen the night before the actual procedure. Number of Clinical Sites: This trial will be conducted in both Canada and USA. Up to ten (10) clinical sites will participate in this trial. The lead Investigator for this trial is Dr Mark V. Larson MD, Head of Digestive Endoscopy, Mayo Clinic, Rochester MN, USA Study population and sample size: Approximately 240 patients will be randomized in this study. Male and female patients having an indication for full colonoscopy, mainly for colorectal cancer screening and surveillance. Only naïve subjects, i.e. who never underwent colonoscopy before, will be eligible. Inclusion Criteria See Eligibility Section Exclusion Criteria See Eligibility Section Study Drugs Administration and Schedule: GIC-1001, or its matching placebo will be administered as follows: One tablet TID on an empty stomach for three (3) consecutive days prior to colonoscopy. Last dose taken at the clinical site at least one (1) hour prior to beginning of procedure (endoscope insertion). Bowel preparation to be performed using PEG based regimen the day before the actual procedure. Three (3) different GIC-1001 dose levels will be studied: 250 mg TID 375 mg TID 500 mg TID Matching placebo TID Concomitant Medications 9.1 Prior to colonoscopy, the following medication will be permitted: Aspirin (ASA) at low levels for cardiovascular health, if dose and regimen stable for the last 6 months prior to colonoscopy. 9.2 The following medications and foods will be prohibited: Any prescription chronic analgesic narcotic, anti-spasmodic, anti-inflammatory medications are forbidden for 30 days prior to screening. (i.e. Washout ≥ 30 days) Selective Serotonin Re-uptake Inhibitors (SSRIs) are forbidden for 30 days prior to screening, unless patient has been on a stable dose for 3 consecutive months prior to screening. Over-the-counter analgesics, or anti-inflammatory medication, oral or topical used for acute pain treatment must be washed out for ≥ 7days prior to screening. Acute or as needed prescription or non-prescription anti-inflammatory and/or analgesic treatment within one (1) week prior to colonoscopy. Use of bowel stimulant laxatives, such bisacodyl, within one (1) week preceding randomization. Use of antidiarrheic medication, such as diphenoxylate, loperamide, kaopectate or bismuth salts, within one (1) week preceding randomization. Administration of barium enema within two (2) weeks preceding randomization. Colonic irritant beverages or foods, such as caffeine-containing beverages (e.g. coffee, Coca-Cola), spices, as well as foods containing seeds (i.e. tomatoes, strawberries, kiwis, raspberries) within 24 hours preceding colonoscopy. Use of any other investigational drug is prohibited unless discontinued, within at least 30 days prior to randomization. Additionally, Prior and Concomitant Medications are to be recorded in the CRF starting 30 days prior to Screening Visit CLV1. Efficacy Evaluation: Colonic analgesic clinical efficacy of GIC-1001 will be measured using a continuous, horizontal 100-mm VAS, at pre-determined times and colonic anatomical segments. At least 8 measurements will be done by the participating patients themselves (see Primary Endpoint section). Subjects will receive proper instructions on the use of the VAS prior to colonoscopy. Overall experience of visceral pain (if any) will be evaluated using the AUC constructed from all calculated VAS self-measurements for each patient. Additional, secondary, efficacy endpoints will also be measured, including time-to-caecum, colonoscopy completion rate and antispasmodic activity. Safety Evaluation: Safety will be assessed using the performance of physical exams, ECG, various laboratory safety tests and the occurrence of adverse events. AEs will be mapped to MedDRA, version 16. Sample Size Considerations: It has been reported in the medical literature that a MCID range of 10-15 mm on the 100-mm VAS is clinical significant in the evaluation of colonoscopy-related visceral pain. Using this value, with an alpha of 0.05 and a beta of 0.9, about 50 patients would be needed in each active arm considering a 90-patient placebo arm. Total study sample size is then estimated at approximately 240 randomized patients. Statistical Analysis: The primary outcome measure will be the mean 100-mm VAS AUC in each treatment arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cancer, Colonic Diseases
Keywords
colonoscopy, sedation-free, colorectal cancer, CRC screening, prevention, analgesia, colonic, kappa, opioid agonist, pain management, oral, hydrogen sulfide, peripheral

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GIC-1001 low dose
Arm Type
Experimental
Arm Description
GIC-1001 , 250 mg TID during 3 consecutive days + a last, 10th dose in the morning of Day 4 (colonoscopy day)
Arm Title
GIC-1001 mid-dose
Arm Type
Experimental
Arm Description
GIC-1001 , 375 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
Arm Title
GIC-1001 , high dose
Arm Type
Experimental
Arm Description
GIC-1001 , 500 mg TID during 3 consecutive days + a 10th dose in the morning of day 4 (colonoscopy day)
Arm Title
GIC-1001 matching placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, TID during 3 consecutive days, + a 10 th dose in the morning of day 4 (colonoscopy day)
Intervention Type
Drug
Intervention Name(s)
GIC-1001
Other Intervention Name(s)
trimebutine 3-thiocarbamoylbenzenesulfonate, TB-905-02
Intervention Description
GIC-1001 oral tablet, white-coated, to be taken with water
Primary Outcome Measure Information:
Title
Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)
Description
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
Time Frame
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 Outcome Measure Information:
Title
Time to Caecum
Description
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.
Time Frame
From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.
Title
Colonoscopy Completion Rate (%)
Description
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.
Time Frame
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.
Title
Safety-Plasma Concentrations of Trimebutine and N-Desmethyl-Trimebutine
Description
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
Time Frame
Day 4 prior to colonoscopy.
Title
Total Examination Time (Colonoscopy)
Description
Defined as the time from endoscope insertion to complete removal of the endoscope; measured in minutes
Time Frame
From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.
Title
Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal
Description
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
Time Frame
From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.
Title
Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal
Description
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
Time Frame
From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.
Title
Patient's Willingness to Repeat Experience
Description
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.
Time Frame
Post-colonoscopy- during subject recovery
Title
Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain
Description
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.
Time Frame
Post-colonoscopy- during subject recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed and dated written Informed Consent obtained. Males or females. Aged 40-75 years. Indication for full colonoscopy for colorectal cancer screening or investigation, including subjects presenting suggestive symptoms and who need a differential diagnosis. 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 Eligible for a procedure without sedation. 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 BMI ≥ 19, BMI ≤ 40 kg/m2. Exclusion Criteria: Known allergy or intolerance to trimebutine (Modulon® or generic). Known allergy or intolerance to sulfur-containing drugs (e.g. N-acetylcysteine or captopril). 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. Diagnosed Inflammatory Bowel Disease (IBD). Visceral hypersensitivity conditions such as Irritable Bowel Syndrome (IBS). Clinically significant renal and/or hepatic impairment. History of peritonitis. Known severe diverticular disease. Severe diverticulosis as documented by prior imaging series Known or suspected stenosis of the colon. Chronic pain syndrome such as fibromyalgia and endometriosis. 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 Unexpected and significant visceral pain reported by subject prior to colonoscopy. Dementia. 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. Patient is a lactating female. 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. 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. Any serious medical condition that could increase the risk of adverse reactions with trimebutine. Participation in another experimental drug trial within 30 days of randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark V Larson, MD
Organizational Affiliation
Mayo Clinic, Rochester, MN, USA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael DeMicco, MD
Organizational Affiliation
Anaheim Clinical Trials, Anaheim, CA, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Lamet, MD
Organizational Affiliation
The Center of GI Disorders, Hollwood, FL, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taddese Desta, MD
Organizational Affiliation
Precision Research Institute, San Diego, CA, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia Schaeffer, MD
Organizational Affiliation
Precision Research Institute, Chula Vista, CA, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vivek Gumaste, MD
Organizational Affiliation
Montefiore Medical Center, NY, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theadore Ptak, MD
Organizational Affiliation
Toronto Digestive Disease Associates, Toronto, ON, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anand Sahai, MD
Organizational Affiliation
Clinique 1037, Montreal, QC, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Umedchandra Shah, MD
Organizational Affiliation
Mid-Atlantic Medical Research Centers, Hollyword, MD, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suryakanth R. Gurudu, MD
Organizational Affiliation
Mayo Clinical, Scottsdale Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Enns, MD
Organizational Affiliation
GIRI (GI Research Institute), Vancouver, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Narayanachar S Murali, MD
Organizational Affiliation
Gastroenterology Associates of Orangeburg, SC, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vishal Gupta, MD
Organizational Affiliation
Avail Clinical Research LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert Cohen, MD
Organizational Affiliation
Spécialistes MD Specialists
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vitaly Fishbein, MD
Organizational Affiliation
PharmaTrials
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dennis Riff, MD
Organizational Affiliation
Anaheim Clinical Trials
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Precision Research Institute
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Avail Clinical Research LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
The Center for GI Disorders
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mid-Atlantic Medical Research Centers
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55910
Country
United States
Facility Name
PharmaTrials
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Gastroenterology Associates of Orangeburg
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GIRI (GI Research Institute)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Toronto Digestive Disease Associates
City
Toronto
State/Province
Ontario
ZIP/Postal Code
L4L4Y7
Country
Canada
Facility Name
Clinique 1037
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X3H9
Country
Canada
Facility Name
Spécialistes MD Specialists
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3Z 2P9
Country
Canada

12. IPD Sharing Statement

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A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy

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