Status:
COMPLETED
A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Colon Cleansing in Preparation for Colonoscopy
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
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 dos...
Detailed Description
This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in Japanese patients. Patients, who signed an informed consent and fulfilled all screening criteria, were randomize...
Eligibility Criteria
Inclusion
- 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
- 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)
- Ascites.
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT02215954
Start Date
September 1 2014
End Date
December 1 2014
Last Update
July 17 2017
Active Locations (4)
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1
Investigational site
Chiba, Japan
2
Investigational site
Kanagawa, Japan
3
Investigational site
Kochi, Japan
4
Investigational site
Tokyo, Japan