Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate
This study has been completed.
Sponsor:
Promefarm S.r.l.
Information provided by (Responsible Party):
Promefarm S.r.l.
ClinicalTrials.gov Identifier:
NCT01509131
First received: January 4, 2012
Last updated: January 11, 2012
Last verified: January 2012
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Purpose
It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: 2L PEG-CS plus bisacodyl Drug: 2L PEG-ASC |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC |
Resource links provided by NLM:
MedlinePlus related topics:
Colonoscopy
Drug Information available for:
Bisacodyl
U.S. FDA Resources
Further study details as provided by Promefarm S.r.l.:
Primary Outcome Measures:
- Evaluation of the quality of bowel preparation by BBPS [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.
Secondary Outcome Measures:
- Difference in mucosal visibility between the two groups [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]Three point rating scale(0-2).
- Number of patients with adverse events [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]Patient questioning.
- Difference in tolerability between the two groups [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation.
- Difference in patients acceptability between the two groups [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation.
- Difference in patients compliance between the two groups [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Difference in the percentage of patients who took at least 75% of bowel preparation.
| Enrollment: | 408 |
| Study Start Date: | March 2010 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2L PEG-CS plus bisacodyl
Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit)
|
Drug: 2L PEG-CS plus bisacodyl
Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)
Other Name: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)
|
|
Active Comparator: 2L PEG-ASC
Patients will be asked to take PEG-ASC according to labeling instructions
|
Drug: 2L PEG-ASC
Patients will asked to take PEG-ASC according to labeling instructions
Other Name: Moviprep
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Out-patients undergoing a complete colonoscopy
- Patient written informed consent
Exclusion Criteria:
- Pregnant or lactating women or at a risk of becoming pregnant
- Hypersensitivity to any of the ingredients
- History of anaphylaxis to drugs or allergic reactions in general
- Known or suspected gastrointestinal obstruction or perforation
- Toxic megacolon; major colonic resection
- Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
- Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
- Unwillingness to co-operate and to comply with the requirements of the trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509131
Locations
| Italy | |
| IRCCS Ospedale Casa Sollievo della Sofferenza | |
| San Giovanni Rotondo, Foggia, Italy, 71013 | |
| IRCCS Humanitas | |
| Rozzano, Milano, Italy, 20089 | |
| Spedali Civili | |
| Brescia, Italy, 25123 | |
| Azienda Ospedaliero Universitaria Careggi | |
| Firenze, Italy, 50134 | |
| Nuovo Regina Margherita | |
| Roma, Italy, 00185 | |
Sponsors and Collaborators
Promefarm S.r.l.
Investigators
| Principal Investigator: | Alessandro Repici, MD | IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy |
| Principal Investigator: | Renzo Cestari, Prof. MD | Spedali Civili di Brescia, Brescia - Italy |
| Principal Investigator: | Cesare Hassan, MD | Nuovo Regina Margherita, Roma - Italy |
| Principal Investigator: | Angelo Andriulli, MD | IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - Italy |
| Principal Investigator: | Vito Annese, MD | Ospedale Careggi, Firenze - Italy |
More Information
No publications provided
| Responsible Party: | Promefarm S.r.l. |
| ClinicalTrials.gov Identifier: | NCT01509131 History of Changes |
| Other Study ID Numbers: | PMF105BC1/09 |
| Study First Received: | January 4, 2012 |
| Last Updated: | January 11, 2012 |
| Health Authority: | Italy: Ethics Committee |
Additional relevant MeSH terms:
|
Bisacodyl Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013