Status:
COMPLETED
A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Bowel Cleansing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule f...
Eligibility Criteria
Inclusion
- Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy
- Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to the colonoscopy
Exclusion
- Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
- 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, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
- Ascites
- Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
- Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
- Severely reduced renal function (Glomerular filtration rate (GFR) \<30 (mL/min/1.73 m2))
- The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded:
- Transdermal patch
- Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
- Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
- Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
- Sexual abstinence
- The subject is a breast-feeding or lactating woman
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02239692
Start Date
November 1 2014
End Date
June 1 2015
Last Update
June 23 2016
Active Locations (3)
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1
Ed Herriot Hopital (there may be other sites in this country)
Lyon, France
2
Gastroenterologie am Bayerischen Platz (there may be other sites in this country)
Berlin, Germany
3
Medisch Centrum Alkmaar (there may be other sites in this country)
Alkmaar, Netherlands