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

NCT ID: NCT02239692

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-06-30

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 for colon cleansing in preparation for colonoscopy.

Conditions

Bowel Cleansing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

PICOPREP day-before dosing schedule

Both doses administered the day before colonoscopy.

Group Type: ACTIVE_COMPARATOR

PICOPREP

Intervention Type: DRUG

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

PICOPREP tailored dosing schedule

First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.

Group Type: EXPERIMENTAL

PICOPREP

Intervention Type: DRUG

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

Interventions

PICOPREP

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Ed Herriot Hopital (there may be other sites in this country)

Lyon, , France

Gastroenterologie am Bayerischen Platz (there may be other sites in this country)

Berlin, , Germany

Medisch Centrum Alkmaar (there may be other sites in this country)

Alkmaar, , Netherlands

Countries

France; Germany; Netherlands

References

Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.

Reference Type: DERIVED

PMID: 28393103 (View on PubMed)

Other Identifiers

2014-001062-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

000121

Identifier Type: -

Identifier Source: org_study_id