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

Bowel Cleansing Clinical Trial

— OPTIMA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239692
• Other study ID #: 000121
• Secondary ID: 2014-001062-10
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2014
• Last updated: June 15, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a tailored PICOPREP dosing schedule to the day-before PICOPREP dosing schedule for colon cleansing in preparation for colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Bowel Cleansing

Intervention

Drug:
• PICOPREP
Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution

Locations

Country	Name	City	State
France	Ed Herriot Hopital (there may be other sites in this country)	Lyon
Germany	Gastroenterologie am Bayerischen Platz (there may be other sites in this country)	Berlin
Netherlands	Medisch Centrum Alkmaar (there may be other sites in this country)	Alkmaar

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall colon cleansing procedure	Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules	Day 1 (day of colonoscopy)	No
Secondary	Ascending colon cleansing	Percentage of subjects classified as success, i.e. excellent or good, measured by the Ottawa Scale performed by a colonoscopist blinded to the dosing schedules	Day 1 (day of colonoscopy)	No
Secondary	Frequency and intensity of adverse events		From baseline (screening) up to day 10 after colonoscopy	Yes
Secondary	Clinically significant changes in vital signs (pulse and blood pressure)		From baseline (screening) up to day 10 after colonoscopy	No
Secondary	Clinically significant changes in laboratory values (haematology, clinical chemistry, coagulation and urinalysis)		From baseline (screening) up to day 10 after colonoscopy	No