Colon Cleansing in Preparation for Colonoscopy or Colorectal Surgery Clinical Trial
Official title:
A Phase III, Randomized, Assessor-Blinded, Parallel-Group, Multi-Centre, Clinical Study With FE 999169 for Oral Administration Versus Niflec® for Colon Cleansing: J-CLEAR
To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.
| Status | Completed |
| Enrollment | 637 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Japanese patients, age 20 to 80 years inclusive, requiring colonoscopy - Female patients should be post-menopausal (women =45 years with no menstrual period for at least 12 months without an alternative medical cause), or be surgically sterile, or be using medically approved contraception, throughout the trial period. - Fertile female patients must have a confirmed negative pregnancy test at screening and randomization - Patients must have had more than or equal to 3 spontaneous bowel movements per week prior to the colonoscopy - Written informed consent obtained prior to any study-related procedure Exclusion Criteria: - Acute surgical abdominal conditions, such as acute intestinal obstruction or intestinal perforation, diverticulitis, appendicitis. If intestinal obstruction and perforation are suspected, perform appropriate diagnostic studies to rule out these conditions - Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD) - Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures - Colon disease (history of colonic cancer, toxic megacolon, idiopathic pseudo-obstruction, hypomotility syndrome) - Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus) - Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass) - Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension - Renal insufficiency (any of the serum creatinine, or serum potassium value exceeding the upper limits of the normal range at screening) or a history of this event - Participation in any other clinical trial during the past 3 months - Any clinically significant laboratory value at screening, including pre-existing electrolyte abnormality, based on clinical history that the investigators feel may affect the study evaluation - Hypersensitivity to active ingredients - Subject who cannot suspend the prohibited medications - Subjects not appropriate to participate in the study as deemed by the investigator |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Investigational site | Chiba | |
| Japan | Investigational site | Kanagawa | |
| Japan | Investigational site | Kochi | |
| Japan | Investigational site | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The efficacy rate based on the overall colon cleansing effect as assessed by the independent central judging committee using the Japanese colon cleansing scale | Rate of responders is defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale | Day 1 (day of colonoscopy) | No |
| Secondary | The efficacy rate based on the overall colon cleansing effect assessed by the investigators at the sites using the Japanese colon cleansing scale | Rate of responders is defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale | Day 1 (day of colonoscopy) | No |
| Secondary | The total scores of the colon cleansing effect by the investigators at sites using the Ottawa scale | Day 1 (day of colonoscopy) | No | |
| Secondary | Evaluation of acceptability of the investigational medicinal products (IMPs) by subjects using a questionnaire | Day 0 - Day 1 | No |