Comparator Study of PEG 3350 Versus Prucalopride in Females With Chronic Constipation
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|ClinicalTrials.gov Identifier: NCT01251822|
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : August 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: PEG 3350 plus electrolytes Drug: Prucalopride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Double-dummy, Double-blind, Randomised, Parallel Group, Controlled Comparative Study of Polyethylene Glycol (PEG)Plus Electrolytes Versus Prucalopride in Females With Chronic Constipation Who Failed Adequate Relief With Laxatives|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||December 2011|
Experimental: PEG 3350
PEG 3350 plus electrolytes in solution plus placebo tablets
Drug: PEG 3350 plus electrolytes
Each sachet of PEG 3350 is dissolved in 125 mL of water. Patients receive two sachets of PEG 3350 plus electrolytes followed by two placebo tablets for the first 14 days, after which dosage adjustment is permitted, according to effect. Each patient is treated for 28 days in total.
Active Comparator: Prucalopride
Prucalopride tablets plus placebo solution
Patients less than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by two prucalopride 1 mg tablets for 28 days.
Patients more than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by one prucalopride 1 mg tablet and one placebo tablet for 28 days.
- Number of spontaneous bowel movements [ Time Frame: Days 22 to 28 of treatment ]Proportion of patients having normal number of spontaneous bowel movements during the last treatment week.
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): NCT01251822
|Timisoara, Romania, RO-300244|
|Principal Investigator:||Rodica Cinci, Prof Dr||Pierrel Research|