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

NCT00598338 | Completed Phase 3

• 1 other identifier: PRU-USA-28
• Study Type: interventional
• Target: 516
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Proportion (%) of subjects with three or more spontaneous, complete bowel movements per week.

  8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Prucalopride

Drug: Prucalopride

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Prucalopride DRUG

4 mg o.d.

Also known as: Resolor

1

Placebo OTHER

o.d.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant, non-breast-feeding female outpatients at least 18 years of age (no upper age limit).
• 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.

You may not qualify if:

• Willing and able to fill out his/her own diary and questionnaires without help, and able to read and write English.
• Written informed consent, signed by the patient or legally acceptable representative and by the investigator.
• Availability for follow-up during the study period as determined in the protocol.
• Patients in whom constipation was thought to be drug-induced, or who were using any disallowed medication
• Patients with insulin-dependent diabetes mellitus.
• Patients suffering from endocrine disorders.
• Patients suffering from neurologic disorders
• Presence of a 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. 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.
• Presence of known serious, uncontrolled illnesses: clinically significant cardiac, vascular, pulmonary, endocrine, psychiatric disorders (including active alcohol or drug abuse) or metabolic disturbances.
• Clinically significant cancer within the past 5 years.
• Subjects known to be HIV positive.
• Impaired renal function, i.e. serum creatinine concentration \>2 mg/dL (\>180 micromol/L) or creatinine clearance ≤50 mL/min.
• Clinically significant abnormalities of haematology, urinalysis, or blood chemistry.

Sponsors & Collaborators

• Movetis: lead

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miner, Jr. B Miner, MD

  Oklahoma Foundation for Digestive Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 21, 2008
• Study Start: April 1, 1999
• Primary Completion: February 1, 2000
• Study Completion: February 1, 2000
• Last Updated: May 29, 2008

Record last verified: 2008-01