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Completed

NCT Number: NCT02239692

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

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.

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Key information

Conditions

Bowel Cleansing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

PICOPREP

Drug

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

Primary outcomes

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

    Time frame: Day 1 (day of colonoscopy)

    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).

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

    Time frame: Day 1 (day of colonoscopy)

    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).

Secondary outcomes

  1. Ascending Colon Cleansing Responder Status (ITT)

    Time frame: Day 1 (day of colonoscopy)

    Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.

  2. Frequency and Intensity of Adverse Events

    Time frame: From baseline (screening) up to day 10 after colonoscopy

  3. 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)

    Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).

  4. 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)

    Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: OPTIMA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2014
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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