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

NCT00487422 | Completed Phase 3

• 1 other identifier: PRU-INT-12
• Study Type: interventional
• Target: 303
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Constipation

Keywords

constipation; prucalopride; QOL; SCBM; PAC-SYM

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with an average of 3 or more SCBM per week

  12 weeks

Secondary Outcomes (1)

• Secondary efficacy variables: 1)Symptom variables 2)QOL variables

  12 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Prucalopride

Drug: prucalopride

2

ACTIVE COMPARATOR

Prucalopride

Drug: Prucalopride

3

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Prucalopride DRUG

2 mg o.d.

Also known as: Resolor

1

Placebo OTHER

o.d.

3

Eligibility Criteria

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

You may qualify if:

• Male and female subjects of 65 or over 65 years of age.
• History of constipation; the subject reports, on average, two or 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:
• 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 stools. 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.

You may not qualify if:

• Subjects in whom constipation is thought to be drug-induced, or subjects using any disallowed medication.
• Subjects suffering from endocrine disorders, metabolic disorders or neurologic disorders.
• Subjects with the main complaint of abdominal pain.
• Subjects with a known 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.
• Malignancies or AIDS.
• Known serious illnesses: clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric or metabolic disturbances. Patients with known diverticulosis may be included.
• Subjects with a serum creatinine concentration \> 2 mg/dL (\> 180 micromol/L).
• Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.

Sponsors & Collaborators

• Movetis: lead

Related Publications (1)

• Muller-Lissner S, Rykx A, Kerstens R, Vandeplassche L. A double-blind, placebo-controlled study of prucalopride in elderly patients with chronic constipation. Neurogastroenterol Motil. 2010 Sep;22(9):991-8, e255. doi: 10.1111/j.1365-2982.2010.01533.x. Epub 2010 Jun 7.

  PMID: 20529205 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

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

Study Officials

• Gerald Demschik, M.D.

  Geriatriezentrum am Wienerwald

  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: June 14, 2007
• First Posted: June 18, 2007
• Study Start: October 1, 1998
• Primary Completion: September 1, 1999
• Study Completion: September 1, 1999
• Last Updated: May 29, 2008

Record last verified: 2007-06