Trial record 2 of 5 for:    colon cleansing AND Ferring

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02239692
First received: September 9, 2014
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Bowel Cleansing
Drug: PICOPREP
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Overall colon cleansing procedure [ Time Frame: Day 1 (day of colonoscopy) ] [ Designated as safety issue: No ]
    Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules


Secondary Outcome Measures:
  • Ascending colon cleansing [ Time Frame: Day 1 (day of colonoscopy) ] [ Designated as safety issue: No ]
    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

  • Frequency and intensity of adverse events [ Time Frame: From baseline (screening) up to day 10 after colonoscopy ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in vital signs (pulse and blood pressure) [ Time Frame: From baseline (screening) up to day 10 after colonoscopy ] [ Designated as safety issue: No ]
  • Clinically significant changes in laboratory values (haematology, clinical chemistry, coagulation and urinalysis) [ Time Frame: From baseline (screening) up to day 10 after colonoscopy ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
Study Start Date: October 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PICOPREP day-before dosing schedule
Both doses administered the day before colonoscopy.
Drug: PICOPREP
Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
Experimental: 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.
Drug: PICOPREP
Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02239692

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
France
Ed Herriot Hopital (there may be other sites in this country) Not yet recruiting
Lyon, France
Germany
Gastroenterologie am Bayerischen Platz (there may be other sites in this country) Not yet recruiting
Berlin, Germany
Netherlands
Medisch Centrum Alkmaar (there may be other sites in this country) Not yet recruiting
Alkmaar, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02239692     History of Changes
Other Study ID Numbers: 000121, 2014-001062-10
Study First Received: September 9, 2014
Last Updated: September 11, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014