Ensayos clínicos

This study has been completed

Inclusion Criteria

• Signed and dated written Informed Consent obtained
• Males or females
• Age 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 enrollment
• 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,  an appendectomy is eligible.
  • A tubal ligation at least 10 years prior (i.e. ≥ 10 years) to enrollment is also eligible
• Diagnosed Inflammatory Bowel Disease
• Visceral hypersensitivity conditions such as Irritable Bowel Syndrome
• 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
• Lactating
• Female, of childbearing potential and sexually active, unwilling or unable to use an acceptable method of contraception ( includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, use of a condom by the sexual partner or a sterile sexual partner) throughout the duration of the study and 1 month following study completion
• Female, of childbearing potential, sexually abstinent, does not agree to continue abstinence or  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