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Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prucalopride
Placebo
Prucalopride
Prucalopride
Sponsored by
Movetis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Outcomes

    Primary Outcome Measures

    Evaluation of the efficacy of prucalopride and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo

    Secondary Outcome Measures

    Evaluation of the effects of R093877 on symptoms associated with idiopathic constipation

    Full Information

    First Posted
    February 6, 2008
    Last Updated
    May 28, 2008
    Sponsor
    Movetis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00617513
    Brief Title
    Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1995 (undefined)
    Primary Completion Date
    March 1996 (Actual)
    Study Completion Date
    March 1996 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Movetis

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic idiopathic constipation. Hypothesis: Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic constipation whereas 0,5 mg is a suboptimal dose.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    174 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Prucalopride
    Other Intervention Name(s)
    Resolor
    Intervention Description
    0.5 mg once daily
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    o.d.
    Intervention Type
    Drug
    Intervention Name(s)
    Prucalopride
    Other Intervention Name(s)
    Resolor
    Intervention Description
    1 mg o.d.
    Intervention Type
    Drug
    Intervention Name(s)
    Prucalopride
    Other Intervention Name(s)
    Resolor
    Intervention Description
    2 mg o.d.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Evaluation of the effects of R093877 on symptoms associated with idiopathic constipation
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 : two or fewer spontaneous* bowel movements in a week. lumpy (scyballae) and/or hard stools at least a quarter of the stools. sensation of incomplete evacuation following at least a quarter of the stools. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marc Van Outryve, MD
    Organizational Affiliation
    Jan Palfijn Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24732867
    Citation
    Emmanuel A, Cools M, Vandeplassche L, Kerstens R. Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis. Am J Gastroenterol. 2014 Jun;109(6):887-94. doi: 10.1038/ajg.2014.74. Epub 2014 Apr 15.
    Results Reference
    derived

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    Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation

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