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Efficacy and Safety Study of the Effect of Dose-Titration of Prucalopride for The Treatment of Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
Movetis
ClinicalTrials.gov Identifier:
NCT00577018
First received: December 17, 2007
Last updated: May 28, 2008
Last verified: December 2007
  Purpose

The purpose of this study is to determine the safety profile of 4 mg prucalopride in the treatment of 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 Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dose-Titration on the Safety and Efficacy and R108512 Tablets in Subjects With Chronic Constipation

Resource links provided by NLM:


Further study details as provided by Movetis:

Primary Outcome Measures:
  • Proportion of patients with an average of ≥3 SCBM/week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with an average increase of ≥1 SCBM/week [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 755
Study Start Date: August 1998
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Prucalopride
4 mg o.d.
Other Name: Resolor
Active Comparator: 2 Drug: Prucalopride
1 mg o.d. for 2 days, 2 mg o.d. for 2 days and 4 mg o.d. thereafter
Other Name: Resolor
Placebo Comparator: 3 Other: Placebo
o.d.

Detailed Description:

To evaluate the potential differences in the adverse event (safety) profile between 4 mg of prucalopride daily for 4 weeks; titration up to a 4-mg total daily dose of prucalopride by starting at 1 mg for 2 days, 2 mg for 2 days, to 4 mg thereafter; and placebo given as oral tablets once daily for 4 weeks in patients with chronic constipation

  Eligibility

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

Inclusion Criteria:

  • Male and non-pregnant, non-breast feeding female subjects at least 18 years of age (no upper age limit);
  • History of constipation. The subject reported having on average, 2 or fewer spontaneous bowel movements per week that resulted in a feeling or sensation 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 for at least a quarter of the stools; sensation of incomplete evacuation following at least a quarter of the stools; or straining at defecation at least a quarter of the time. The above criteria only applied to spontaneous bowel movements, (i.e., not preceded within a period of 24 hours by the intake of a laxative or use of an enema). A subject who never had spontaneous bowel movements was considered to be constipated and therefore eligible for the trial;
  • Constipation that was functional (i.e., not secondary to other causes);
  • Willingness and ability to fill out own diary and questionnaires;
  • Written informed consent, signed by the subject or legally acceptable representative and by the investigator; and
  • Availability for follow-up during the trial period, as determined in the protocol.

Exclusion Criteria:

  • Subjects in whom constipation was thought to be drug-induced or who were using any disallowed medication;
  • Subjects suffering from secondary causes of chronic constipation. For example:

Endocrine disorders: insulin-dependent diabetes mellitus; hypopituitarism; hypothyroidism; hypercalcemia; pseudo-hypoparathyroidism; pheochromocytoma; or glucagon-producing tumors. Endocrine disorders controlled by appropriate medical therapy were not excluded, with the exception of insulin-dependent diabetes mellitus Metabolic disorders: porphyria; uremia; hypokalemia; or amyloid neuropathy. Metabolic disorders controlled by appropriate medical therapy were not excluded

• Exclusion criteria (cont'd): Neurologic disorders: Parkinson's disease; cerebral tumors; cerebrovascular accidents; multiple sclerosis; meningocele; aganglionosis; hypoganglionosis; hyperganglionosis; autonomic neuropathy; spinal cord injury; Chagas' disease; or major depression

  • Presence of megacolon/megarectum or a diagnosis of pseudo-obstruction;
  • Constipation as a result of surgery;
  • 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. An examination performed within the last 3 years was acceptable, if the examination had been performed for an evaluation of constipation, if there was no history or evidence of weight loss, anemia, or rectal bleeding, and if the subject had had three consecutively negative stool occult blood tests at screening. Subjects with polyps discovered by colonoscopy that were untreated (i.e., by polypectomy) were to be excluded;
  • Presence of severe and clinically uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse);
  • Clinically significant cancer within the past 5 years;
  • Known HIV-positive status or AIDS;
  • Impaired renal function;
  • Clinically significant abnormalities of hematology, urinalysis or blood chemistry;
  • Females of child-bearing potential without adequate contraceptive protection during the trial. Oral contraceptives, Depo-Provera®, or Norplant®) must have been used for at least 3 months prior to randomization. I.U.D.'s, sterilization, or a double-barrier method were other acceptable methods of birth control;
  • Treatment with an investigational drug in the 30 days preceding the run-in phase of the trial; and
  • Previous treatment with either R093877 (prucalopride hydrochloride) or R108512 (prucalopride succinate).
  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: NCT00577018

Sponsors and Collaborators
Movetis
Investigators
Principal Investigator: John F Johanson, MD, MSc Private Practice
  More Information

No publications provided

Responsible Party: Renate Specht Gryp, Movetis
ClinicalTrials.gov Identifier: NCT00577018     History of Changes
Other Study ID Numbers: PRU-USA-25
Study First Received: December 17, 2007
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 November 25, 2014