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

NCT00631813 | Completed Phase 2

• 1 other identifier: PRU-INT-2
• Study Type: interventional
• Target: 253
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine which dose of prucalopride is safe and effective in patients with chronic constipation. Hypothesis: Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic constipation whereas 0,5 mg is a suboptimal dose.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy and to compare the effects of 0.5 mg, 1 mg or 2 mg of R093877 versus placebo

  12 weeks

Secondary Outcomes (1)

• Evaluation of the effects of R093877 on symptoms associated with chronic constipation

  12 weeks

Study Arms (4)

1

ACTIVE COMPARATOR

Prucalopride 0.5 mg

Drug: Prucalopride

2

ACTIVE COMPARATOR

Prucalopride 1 mg

Drug: Prucalopride

3

ACTIVE COMPARATOR

Prucalopride 2 mg

Drug: Prucalopride

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prucalopride DRUG

0.5 mg bid

Also known as: Resolor

1

Placebo DRUG

bid

4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-70 years;
• History of constipation, i.e., the subject reported the occurrence of two or more of the following criteria for at least 6 months before the selection visit:
• two or fewer spontaneous\* bowel movements a week,
• lumpy (scyballae) and/or hard stools at least ¼ of the stools,
• sensation of incomplete evacuation after at least ¼ of the stools,
• straining at defaecation at least ¼ of the time. \*The above criteria were only applicable for spontaneous bowel movements i.e., not preceded within a 24-hour period by the intake of a laxative agent. Subjects who never had a spontaneous bowel movement were considered constipated and eligible to enter the double-blind phase of the trial.
• Constipation being severe and causing disability; the subject's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief;
• Normal inhibition pattern of the external anal sphincter during straining i.e., relaxation of the m.puborectalis and a distal displacement of the rectal canal (digital examination and/or electromyographic and/or manometric evidence was acceptable);
• Poor results with routine laxative treatment and diet counselling;
• Constipation of a functional, i.e., idiopathic nature;
• Written or oral witnessed informed consent;
• Availability for follow-up during the trial period.

You may not qualify if:

• Constipation thought to be drug-induced;
• Presence of secondary causes of constipation, i.e., subjects suffering from types or causes of constipation other than idiopathic constipation, for instance: endocrine disorders, metabolic disorders, or neurologic disorders;
• Congenital megacolon/megarectum;
• History of previous abdominal surgery (other than hysterectomy, surgery for Meckel's diverticle, appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy or fundoplication) thought to be the primary cause of constipation;
• Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease;
• Active proctological conditions thought to be responsible for the constipation;
• Presence of the following ECG abnormalities:
• nd or 3rd degree of AV-block,
• prolonged QT-times (\> 460 ms),
• bradycardia;
• Use of concomitant medication that might cause QT-prolongation;
• Use of diuretics not associated with potassium sparing effects;
• Known illnesses or conditions such as severe cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abused dependence but with the exception of nicotine), alcoholism, cancer or AIDS and other gastrointestinal or endocrine disorders;
• Impaired renal function;
• Presence of a serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT) or a serum glutamic-pyruvic transaminase (SGPT) concentration of \> 2 times the normal limit;

Sponsors & Collaborators

• Movetis: lead

Related Publications (1)

• Emmanuel A, Cools M, Vandeplassche L, Kerstens R. Prucalopride improves bowel function and colonic transit time in patients with chronic constipation: an integrated analysis. Am J Gastroenterol. 2014 Jun;109(6):887-94. doi: 10.1038/ajg.2014.74. Epub 2014 Apr 15.

  PMID: 24732867 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

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

Study Officials

• P. Van Eeghem, MD

  Onze Lieve Vrouw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: March 10, 2008
• Study Start: November 1, 1995
• Primary Completion: April 1, 1997
• Study Completion: April 1, 1997
• Last Updated: May 29, 2008

Record last verified: 2008-02