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

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00485940
First received: June 12, 2007
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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

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


Condition Intervention Phase
Constipation
Drug: Prucalopride
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation

Resource links provided by NLM:


Further study details as provided by Movetis:

Primary Outcome Measures:
  • Proportion of subjects with an average of 3 or more SCBM per week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy variables: 1)Symptom variables 2)QOL variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 641
Study Start Date: March 1998
Study Completion Date: May 1999
Primary Completion Date: May 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Prucalopride 2 mg
Drug: Prucalopride
2 mg o.d.
Other Name: Resolor
Placebo Comparator: 3
Placebo
Other: Placebo
Placebo o.d.
Active Comparator: 2
Prucalopride 4 mg
Drug: Prucalopride
4 mg o.d.
Other Name: Resolor

Detailed Description:

This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week drug-free run-in period, followed by a 12-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 At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial.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. No Dulcolax or enemas should be taken within 48 hours prior to the start of double-blind treatment and 48 hours following the start of double-blind treatment. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and non-pregnant, non breast-feeding female outpatients at least 18 years of age (no upper age limit).
  2. History of constipation; the subject reports, ona average,two of 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:

  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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485940

Sponsors and Collaborators
Movetis
Investigators
Principal Investigator: John F Johanson, M.D. Private practice at Rockford Gastroenterology Associates Ltd. in Rockford
  More Information

Publications:
Tack J, Stanghellini V, Dubois D, Joseph A, Vandeplassche L, Kerstens R. Effect of Prucalopride on Symptoms of Chronic Constipation. Neurogastroenterol Motil 2013 Epub online: 20 Sep 2013.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT00485940     History of Changes
Other Study ID Numbers: PRU-USA-13
Study First Received: June 12, 2007
Last Updated: September 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Movetis:
constipation
prucalopride
QOL
SCBM
PAC-SYM

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

ClinicalTrials.gov processed this record on October 20, 2014