A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02239692
• Date of registration: 09/09/2014
• Prospective Registration: Yes
• Primary sponsor: Ferring Pharmaceuticals
• Public title: A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy OPTIMA
• Scientific title: 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
• Date of first enrolment: November 2014
• Target sample size: 204
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02239692
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France, Germany, Netherlands

Contacts

• Name: Clinical Development Support
• Affiliation: Ferring Pharmaceuticals

Key inclusion & exclusion criteria

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 (ATC code A06AC)) per week for one month prior to
the colonoscopy

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:

1. Transdermal patch

2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive)

3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm
plus spermicide, etc.)

4. Maintenance of a monogamous relationship with a male who has been surgically
sterilised by vasectomy

5. Sexual abstinence

- The subject is a breast-feeding or lactating woman



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bowel Cleansing

Intervention(s)

Drug: PICOPREP

Primary Outcome(s)

Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale [Time Frame: Day 1 (day of colonoscopy)]

Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale [Time Frame: Day 1 (day of colonoscopy)]

Secondary Outcome(s)

Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure) [Time Frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)]

Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis) [Time Frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)]

Ascending Colon Cleansing Responder Status (ITT) [Time Frame: Day 1 (day of colonoscopy)]

Frequency and Intensity of Adverse Events [Time Frame: From baseline (screening) up to day 10 after colonoscopy]

Secondary ID(s)

000121

2014-001062-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/06/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02239692