Efficacy and Safety Study of Prucalopride to Treat Chronic Constipation
NCT ID: NCT00488137
Last Updated: 2013-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
716 participants
INTERVENTIONAL
1998-03-31
1999-07-31
Brief Summary
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Hypothesis:
Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients
Detailed Description
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During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative (Dulcolax) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. No Dulcolax should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to visit 2) and 48 hours following the start of double-blind treatment (48 hours following visit 2). Subjects will enter the double-blind period if constipation is shown to be present during the run-in period.
If the definition of constipation is not met during the 2-week run-in, the subject will be considered ineligible for the double-blind period and will be discontinued from the study.
During the double-blind, randomised, placebo-controlled period, subjects will be treated for 12 weeks with either 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Prucalopride 2 mg
Prucalopride
2 mg o.d.
3
Placebo
Placebo
o.d.
2
Prucalopride 4 mg
Prucalopride
4 mg o.d.
Interventions
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Prucalopride
2 mg o.d.
Placebo
o.d.
Prucalopride
4 mg o.d.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of constipation; the subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and one or more of the following for at least 6 months before the selection visit:
1. very hard (little balls) and/or hard stools at least a quarter of the stools
2. sensation of incomplete evacuation following at least a quarter of the stools
3. straining at defecation at least a quarter of the time. The above criteria are only applicable for spontaneous bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
Subjects who never have spontaneous bowel movements are considered to be constipated and are eligible for the trial.
Exclusion Criteria
2. Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
3. Subjects with a megacolon/megarectum or a diagnosis of pseudo-obstruction.
4. Constipation as a result of surgery.
5. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
6. Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer or AIDS, and other gastrointestinal or endocrine disorders.
7. Subjects with impaired renal function.
8. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
9. Females of child-bearing potential without adequate contraceptive protection during the trial.
18 Years
ALL
No
Sponsors
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Movetis
INDUSTRY
Responsible Party
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Movetis
Principal Investigators
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Ghislain Devroede, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centre Universitaire de Sante
References
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Broad J, Kung VW, Boundouki G, Aziz Q, De Maeyer JH, Knowles CH, Sanger GJ. Cholinergic interactions between donepezil and prucalopride in human colon: potential to treat severe intestinal dysmotility. Br J Pharmacol. 2013 Nov;170(6):1253-61. doi: 10.1111/bph.12397.
Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash BD. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Therap Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024.
Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.
Tack J, Camilleri M, Dubois D, Vandeplassche L, Joseph A, Kerstens R. Association between health-related quality of life and symptoms in patients with chronic constipation: an integrated analysis of three phase 3 trials of prucalopride. Neurogastroenterol Motil. 2015 Mar;27(3):397-405. doi: 10.1111/nmo.12505. Epub 2015 Jan 11.
Tack J, Quigley E, Camilleri M, Vandeplassche L, Kerstens R. Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis. United European Gastroenterol J. 2013 Feb;1(1):48-59. doi: 10.1177/2050640612474651.
Tack J, Stanghellini V, Dubois D, Joseph A, Vandeplassche L, Kerstens R. Effect of prucalopride on symptoms of chronic constipation. Neurogastroenterol Motil. 2014 Jan;26(1):21-7. doi: 10.1111/nmo.12217. Epub 2013 Sep 20.
Tack J, van Outryve M, Beyens G, Kerstens R, Vandeplassche L. Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives. Gut. 2009 Mar;58(3):357-65. doi: 10.1136/gut.2008.162404. Epub 2008 Nov 5.
Other Identifiers
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PRU-INT-6
Identifier Type: -
Identifier Source: org_study_id