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A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy (CLEAR PREP)
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02386449
First received: March 6, 2015
Last updated: January 11, 2016
Last verified: January 2016
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Purpose
This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
| Condition | Intervention | Phase |
|---|---|---|
| Bowel Preparation | Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®) Drug: mannitol Drug: Bisacodyl | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | A Randomized, Controlled, Parallel Group, Assessor-Blinded Study To Compare The Efficacy, Tolerability, And Safety Of Oral Sodium Picosulfate (PicoPrep®) Versus Oral Mannitol and Bisacodyl, For Colon Cleansing In Colonoscopy Preparation Of Adult Outpatients |
Resource links provided by NLM:
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Percentage of subjects classified as success (Aronchick scale) [ Time Frame: At visit 2 (day 1 of colonoscopy) ]Defined as excellent or good according to the Aronchick scale
Secondary Outcome Measures:
- Percentage of subjects classified as success (Ottawa scale) [ Time Frame: At visit 2 (day 1 of colonoscopy) ]Defined as excellent, good or fair according to the Ottawa scale
- Aggregate Tolerability Score (Colonoscopy Preparation Subject Tolerability Questionnaire) [ Time Frame: At visit 2 (day 1 of colonoscopy) ]As assessed by a Colonoscopy Preparation Subject Tolerability Questionnaire
- Subject satisfaction (Likert scale) [ Time Frame: At visit 2 (day 1 of colonoscopy) ]As assessed by a subject survey using a 3 point Likert scale
| Enrollment: | 184 |
| Study Start Date: | February 2015 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Picoprep
sodium picosulfate, magnesium oxide and citric acid
|
Drug: sodium picosulfate, magnesium oxide and citric acid (Picoprep®) |
| Active Comparator: Mannitol and Bisacodyl | Drug: mannitol Drug: Bisacodyl |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men or women aged 18 to 60 years
- Subjects scheduled for an elective colonoscopy
- Women of child-bearing potential using at least one highly effective contraceptive method
- Subjects able to understand all instructions
- Informed consent signed
Exclusion Criteria:
- Hypersensitivity to active ingredients
- Female participants pregnant or with a positive blood pregnancy test
- Acute surgical abdomen
- Previous colorectal surgery
- Gastrointestinal (GI) surgery
- GI diseases, active inflammatory bowel disease, colon disease
- Ascites/hepatic cirrhosis, cardiac disease, advanced pulmonary or renal disease
- Use of laxatives or antidiarrheal agents 72 hours prior to screening
- Significant alterations in laboratory values or other diseases that could interfere with the results
Contacts and Locations
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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: NCT02386449
Please refer to this study by its ClinicalTrials.gov identifier: NCT02386449
Locations
| Brazil | |
| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (there may be other sites in this country) | |
| Sao Paulo, Brazil | |
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02386449 History of Changes |
| Other Study ID Numbers: |
000180 |
| Study First Received: | March 6, 2015 |
| Last Updated: | January 11, 2016 |
Additional relevant MeSH terms:
|
Mannitol Bisacodyl Picosulfate sodium Magnesium Oxide Citric Acid Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs |
Cathartics Gastrointestinal Agents Laxatives Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Antacids |
ClinicalTrials.gov processed this record on July 17, 2017