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

NCT02239692 | Completed Phase 3 Results

• 2 other identifiers: 0001212014-001062-10
• Study Type: interventional
• Target: 204
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale

  Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).

  Day 1 (day of colonoscopy)

• Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale

  Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).

  Day 1 (day of colonoscopy)

Secondary Outcomes (4)

• Ascending Colon Cleansing Responder Status (ITT)

  Day 1 (day of colonoscopy)

• Frequency and Intensity of Adverse Events

  From baseline (screening) up to day 10 after colonoscopy

• Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)

  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)

  From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)

Study Arms (2)

PICOPREP day-before dosing schedule

ACTIVE COMPARATOR

Both doses administered the day before colonoscopy.

Drug: PICOPREP

PICOPREP tailored dosing schedule

EXPERIMENTAL

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.

Drug: PICOPREP

Interventions

PICOPREP DRUG

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

PICOPREP day-before dosing schedule; PICOPREP tailored dosing schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (3)

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

Lyon, France

Location

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

Berlin, Germany

Location

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

Alkmaar, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 28393103 DERIVED

MeSH Terms

Interventions

picosulfate sodium

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 15, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 23, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-05

Locations

NL (1); DE (1); FR (1)