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

NCT00483886 | Completed Phase 3

• 1 other identifier: PRU-USA-11
• Study Type: interventional
• Target: 620
• 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. 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 2 mg

Drug: Prucalopride

3

PLACEBO COMPARATOR

Placebo

Other: Placebo

2

ACTIVE COMPARATOR

Prucalopride 4 mg

Drug: Prucalopride

Interventions

Prucalopride DRUG

2 mg o.d.

Also known as: Resolor

1

Placebo OTHER

Placebo o.d.

3

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 subject reports, on average, two or fewer spontaneous bowel movements per week that result in a feeling of complete evacuation and or 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 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 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.
• \. 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.
• \. Subjects with impaired renal function.
• \. Subjects with clinically significant abnormalities of haematology, urinalysis, or blood chemistry.
• \. Females of child-bearing potential without adequate contraceptive protection during the trial.

Sponsors & Collaborators

• Movetis: lead

Related Publications (6)

• Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash BD. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Therap Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024.

  PMID: 39664231 DERIVED

• Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.

  PMID: 34585675 DERIVED

• Tack J, Camilleri M, Dubois D, Vandeplassche L, Joseph A, Kerstens R. Association between health-related quality of life and symptoms in patients with chronic constipation: an integrated analysis of three phase 3 trials of prucalopride. Neurogastroenterol Motil. 2015 Mar;27(3):397-405. doi: 10.1111/nmo.12505. Epub 2015 Jan 11.

  PMID: 25581251 DERIVED

• Tack J, Quigley E, Camilleri M, Vandeplassche L, Kerstens R. Efficacy and safety of oral prucalopride in women with chronic constipation in whom laxatives have failed: an integrated analysis. United European Gastroenterol J. 2013 Feb;1(1):48-59. doi: 10.1177/2050640612474651.

  PMID: 24917940 DERIVED

• Tack J, Stanghellini V, Dubois D, Joseph A, Vandeplassche L, Kerstens R. Effect of prucalopride on symptoms of chronic constipation. Neurogastroenterol Motil. 2014 Jan;26(1):21-7. doi: 10.1111/nmo.12217. Epub 2013 Sep 20.

  PMID: 24106924 DERIVED

• Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.

  PMID: 18509121 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Camilleri, M.D.

  Mayo Graduate School of Medicine

  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 6, 2007
• First Posted: June 7, 2007
• Study Start: April 1, 1998
• Primary Completion: May 1, 1999
• Study Completion: May 1, 1999
• Last Updated: April 11, 2013

Record last verified: 2013-04