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

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00598338
First received: January 10, 2008
Last updated: May 28, 2008
Last verified: January 2008
  Purpose

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

Hypothesis:

Retreatment is as effective and safe as treatment with prucalopride in patients with chronic constipation.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Period, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of re-Treatment of Prucalopride on Efficacy and Safety in Subjects With Chronic Constipation.

Resource links provided by NLM:


Further study details as provided by Movetis:

Primary Outcome Measures:
  • Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 516
Study Start Date: April 1999
Study Completion Date: February 2000
Primary Completion Date: February 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Prucalopride
Drug: Prucalopride
4 mg o.d.
Other Name: Resolor
Placebo Comparator: 2
Placebo
Other: Placebo
o.d.

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 4-week double-blind, placebo-controlled treatment period, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind treatment period.

During the initial run-in period, the subject's bowel habit will be documented in a daily diary and the existence of constipation will be confirmed. Eligible subjects will be randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given orally once daily before breakfast, for 4 weeks.

After 4 weeks of treatment, each subject will enter a drug-free washout period. The length of the washout period will be either 2 or 4 weeks, depending on how long it takes for the subject to meet the criteria for constipation. If the subject is unable to re-qualify after a 4-week washout, the subject must be discontinued from the trial.

Subjects who qualify for the second double-blind treatment period will receive the same treatment as during the first treatment period, once-daily for an additional four weeks.

  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 patient reported having, on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling of complete evacuation as well as the occurrence of one or more of the following for at least 6 months before the selection visit:

    • very hard (little balls) 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 defecation at least a quarter of the time. The above criteria were 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.

    Patients who never had spontaneous bowel movements were considered to be constipated and were eligible for the study.

  3. Having functional constipation. Constipation that was not induced by secondary causes of constipation (see exclusion criteria 1 through 7).
  4. Willing and able to fill out his/her own diary and questionnaires without help, and able to read and write English.
  5. Written informed consent, signed by the patient or legally acceptable representative and by the investigator.
  6. Availability for follow-up during the study period as determined in the protocol.

Exclusion Criteria:

  1. Patients in whom constipation was thought to be drug-induced, or who were using any disallowed medication
  2. Patients with insulin-dependent diabetes mellitus.
  3. Patients suffering from endocrine disorders.
  4. Patients suffering from neurologic disorders
  5. Presence of a megacolon/megarectum or a diagnosis of pseudo-obstruction.
  6. Constipation as a result of surgery.
  7. Known or suspected organic disorders of the large bowel (i.e. obstruction, carcinoma, or inflammatory bowel disease). Results of a barium enema with flexible sigmoidoscopy or of a colonoscopic examination performed within the last 12 months were needed to rule out organic disorders. A colonoscopic examination or barium enema with flexible sigmoidoscopy performed within the last 3 years was acceptable if the examination was performed for an evaluation of constipation, and there was no history or evidence of weight loss, anaemia, or rectal bleeding, and the patient had 3 consecutively negative stool occult blood tests at screening. Patients with polyps discovered by colonoscopy that were untreated (i.e. by polypectomy) were to be excluded.
  8. Presence of known serious, uncontrolled illnesses: clinically significant cardiac, vascular, pulmonary, endocrine, psychiatric disorders (including active alcohol or drug abuse) or metabolic disturbances.
  9. Clinically significant cancer within the past 5 years.
  10. Subjects known to be HIV positive.
  11. Impaired renal function, i.e. serum creatinine concentration >2 mg/dL (>180 micromol/L) or creatinine clearance ≤50 mL/min.
  12. Clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
  13. Females of child-bearing potential without adequate contraceptive protection during the study. Oral contraceptives, Depo Provera® and Norplant® had to be used for at least 3 months prior to randomisation. Intrauterine devices (IUDs), sterilization, or a double barrier method were other acceptable methods of birth control.
  14. Treatment with an investigational drug in the 30 days preceding the run-in phase of the study.
  15. Previous treatment with either prucalopride formulation.
  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: NCT00598338

Sponsors and Collaborators
Movetis
Investigators
Principal Investigator: Miner, Jr. B Miner, MD Oklahoma Foundation for Digestive Research
  More Information

No publications provided

Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT00598338     History of Changes
Other Study ID Numbers: PRU-USA-28
Study First Received: January 10, 2008
Last Updated: May 28, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014