ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 8 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02239692
Recruitment Status : Completed
First Posted : September 15, 2014
Results First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Bowel Cleansing Drug: PICOPREP Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239692


Locations
France
Ed Herriot Hopital (there may be other sites in this country)
Lyon, France
Germany
Gastroenterologie am Bayerischen Platz (there may be other sites in this country)
Berlin, Germany
Netherlands
Medisch Centrum Alkmaar (there may be other sites in this country)
Alkmaar, Netherlands
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02239692     History of Changes
Other Study ID Numbers: 000121
2014-001062-10 ( EudraCT Number )
First Posted: September 15, 2014    Key Record Dates
Results First Posted: June 23, 2016
Last Update Posted: June 23, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Picosulfate sodium
Cathartics
Gastrointestinal Agents