Clinical trial NCT02239692: A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bowel Cleansing
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-09-15
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
timeFrame: Day 1 (day of colonoscopy)
measure: Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
timeFrame: Day 1 (day of colonoscopy)
Secondary outcomes:
measure: Ascending Colon Cleansing Responder Status (ITT)
timeFrame: Day 1 (day of colonoscopy)
measure: Frequency and Intensity of Adverse Events
timeFrame: From baseline (screening) up to day 10 after colonoscopy
measure: Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
timeFrame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
measure: Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
timeFrame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Ed Herriot Hopital (there may be other sites in this country)
city: Berlin
country: Germany
facility: Gastroenterologie am Bayerischen Platz (there may be other sites in this country)
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.