Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation
NCT ID: NCT00487422
Last Updated: 2008-05-29
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
303 participants
INTERVENTIONAL
1998-10-31
1999-09-30
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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group.
During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 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
prucalopride
2 mg o.d.
2
Prucalopride
Prucalopride
4 mg o.d.
3
Placebo
Placebo
o.d.
Interventions
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prucalopride
2 mg o.d.
Prucalopride
4 mg o.d.
Placebo
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 stools. 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 the main complaint of abdominal pain.
4. Subjects with a known megacolon/megarectum or a diagnosis of pseudo-obstruction.
5. Constipation as a result of surgery.
6. Known or suspected organic disorders of the large bowel, i.e. obstruction, carcinoma, or inflammatory bowel disease.
7. Malignancies or AIDS.
8. Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included.
9. Subjects with a serum creatinine concentration \> 2 mg/dL (\> 180 micromol/L).
10. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
65 Years
ALL
No
Sponsors
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Movetis
INDUSTRY
Responsible Party
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Movetis
Principal Investigators
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Gerald Demschik, M.D.
Role: PRINCIPAL_INVESTIGATOR
Geriatriezentrum am Wienerwald
References
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Muller-Lissner S, Rykx A, Kerstens R, Vandeplassche L. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil. 2010 Sep;22(9):991-8, e255. doi: 10.1111/j.1365-2982.2010.01533.x. Epub 2010 Jun 7.
Other Identifiers
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PRU-INT-12
Identifier Type: -
Identifier Source: org_study_id