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Efficacy and Safety Study of Prucalopride for the Treatment of 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: NCT00617513
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : May 29, 2008
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Brief Summary:

The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic idiopathic constipation.


Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic constipation whereas 0,5 mg is a suboptimal dose.

Condition or disease Intervention/treatment Phase
Constipation Drug: Prucalopride Other: Placebo Phase 2

Detailed Description:

This is a phase II trial with a parallel-group design, consisting of a drug-free run-in phase (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 0.5 mg o.d., 1 mg o.d. or 2 mg o.d. or placebo for a period of 4 weeks.

Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation confirmed. At the start of this period all existing laxative medication is withdrawn but patients will be instructed not to change their dietary habits, in particular their fibre intake during the trial. Patients will enter the double-blind phase if constipation has been shown to be present during the run-in period.

If the definition of constipation was not met during the 4 weeks of the run-in period, double-blind treatment will not be started.

Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 4 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given once daily (one capsule is taken before breakfast).

Patients admitted to the double blind treatment period will be randomly allocated to one of the 4 treatment arms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
Study Start Date : March 1995
Actual Primary Completion Date : March 1996
Actual Study Completion Date : March 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: 1 Drug: Prucalopride
0.5 mg once daily
Other Name: Resolor

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

Active Comparator: 3 Drug: Prucalopride
2 mg o.d.
Other Name: Resolor

Placebo Comparator: 4 Other: Placebo

Primary Outcome Measures :
  1. Evaluation of the efficacy of prucalopride and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Evaluation of the effects of R093877 on symptoms associated with idiopathic constipation [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18-70 years.
  • History of constipation i.e., the patient reported the occurrence of TWO OR MORE of the following criteria for at least 6 months before the selection visit :

    1. two or fewer spontaneous* bowel movements in a week.
    2. lumpy (scyballae) and/or hard stools at least a quarter of the stools.
    3. sensation of incomplete evacuation following at least a quarter of the stools.
    4. straining at defaecation at least a quarter of the time. *A bowel movement was considered spontaneous if it was not preceded by the intake of a laxative agent within a period of 12 hours. An amendment was made changing this period to 24 hours. Moreover, the amendment stated: "Patients who never opened their bowels spontaneously would be considered constipated and eligible to enter the double-blind phase of the trial, whether or not the above mentioned criteria were met for laxativa/enemas induced stools".
  • Constipation causing disability; the patient's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief.
  • Normal electromyographic inhibition pattern of the external anal sphincter during straining (clinical and/or electromyographic and/or manometric evidence is acceptable).
  • Absence of organic abnormalities of the colon on barium enema or on total colonoscopic examination. This criterion was amended to: "If complaints of constipation were of recent onset,i.e., had been present for 6 months to 1 year, results of a colonoscopic examination performed within the last 12 months were needed. If complaints of constipation had been present for more than one year, results of an endoscopic examination performed within the past three years were acceptable".
  • Poor results with laxative treatment and diet counselling.
  • Constipation of a functional, i.e., idiopathic nature.
  • Availability of the patient's written informed consent.
  • Patient available for follow-up during the trial period as determined in the protocol.

Exclusion Criteria:

  • Constipation thought to be drug-induced.
  • Presence of secondary causes of constipation, for instance: endocrine disorders, metabolic disorders, neurologic disorders.
  • Congenital megacolon/megarectum.
  • History of previous abdominal surgery other than hysterectomy, surgery for Meckel's diverticle,appendicectomy, cholecystectomy, inguinal repair, splenectomy, nephrectomy or fundoplication.
  • Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease.
  • Active proctological conditions which were thought to be responsible for constipation.
  • Evidence of a non-relaxing pelvic floor ("anismus") as the main cause of constipation.
  • Clinically significant ECG abnormalities.
  • Known illnesses or conditions which might interfere in any way with the adequate assessment of the drug under study, such as severe cardiovascular or lung disease, neurologic or psychiatric disorders, alcoholism, cancer or AIDS.
  • Impaired renal function
  • Presence of a serum amylase-, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT) concentration of > 2 times the upper limit of normal.
  • Clinically significant abnormalities of blood chemistry, haematology or urinalysis at selection.
  • Pregnancy or wish to become pregnant during the course of the study. - Breast feeding.
  • Investigational drug received in the 30 days preceding the trial.
  • Known use of street drugs e.g., marijuana, cocaine etc.
  • Unability or unwillingness to return for required follow-up visits.
  • Reliability and physical state preventing proper evaluation of a drug trial.

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): NCT00617513

Sponsors and Collaborators
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Principal Investigator: Marc Van Outryve, MD Jan Palfijn Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Renate Specht Gryp, Movetis Identifier: NCT00617513    
Other Study ID Numbers: PRU-INT-1
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs