A randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of the PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy

• Conditions: Bowel cleansing; MedDRA version: 17.0Level: PTClassification code 10066943Term: Bowel preparationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-001062-10-DE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-07
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• 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 (ACT code A06AC)) per week for one month prior to the colonoscopy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118

Exclusion Criteria

• 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:
a.Transdermal patch
b.Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
c.Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
d.Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
e.Sexual abstinence
• The subject is a breast-feeding or lactating woman

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified