Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487422
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : May 29, 2008
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Brief Summary:

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients.


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

Condition or disease Intervention/treatment Phase
Constipation Drug: prucalopride Drug: Prucalopride Other: Placebo Phase 3

Detailed Description:

This is a multicentre, randomised, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 4-week, double-blind, placebo-controlled treatment period.

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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation
Study Start Date : October 1998
Actual Primary Completion Date : September 1999
Actual Study Completion Date : September 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: 1
Drug: prucalopride
2 mg o.d.
Other Name: Resolor

Active Comparator: 2
Drug: Prucalopride
4 mg o.d.
Other Name: Resolor

Placebo Comparator: 3
Other: Placebo

Primary Outcome Measures :
  1. Proportion of subjects with an average of 3 or more SCBM per week [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Secondary efficacy variables: 1)Symptom variables 2)QOL variables [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female subjects of 65 or over 65 years of age.
  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:

  1. Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
  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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00487422

Sponsors and Collaborators
Principal Investigator: Gerald Demschik, M.D. Geriatriezentrum am Wienerwald

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis Identifier: NCT00487422     History of Changes
Other Study ID Numbers: PRU-INT-12
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: June 2007

Keywords provided by Movetis:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms