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

NCT00617513 | Completed Phase 2

• 1 other identifier: PRU-INT-1
• Study Type: interventional
• Target: 174
• 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 idiopathic constipation. Hypothesis: Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic constipation whereas 0,5 mg is a suboptimal dose.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (4)

1

ACTIVE COMPARATOR

Drug: Prucalopride

2

ACTIVE COMPARATOR

Drug: Prucalopride

3

ACTIVE COMPARATOR

Drug: Prucalopride

4

PLACEBO COMPARATOR

Other: Placebo

Interventions

Prucalopride DRUG

0.5 mg once daily

Also known as: Resolor

1

Placebo OTHER

o.d.

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 patient 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 in a week.
• lumpy (scyballae) 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 defaecation at least a quarter of the time. \*A bowel movement was considered spontaneous if it was not preceded by the intake of a laxative agent within a period of 12 hours. An amendment was made changing this period to 24 hours. Moreover, the amendment stated: "Patients who never opened their bowels spontaneously would be considered constipated and eligible to enter the double-blind phase of the trial, whether or not the above mentioned criteria were met for laxativa/enemas induced stools".
• Constipation causing disability; the patient's occupational, social and recreational activities were governed by his/her constipation and efforts to attain relief.
• Normal electromyographic inhibition pattern of the external anal sphincter during straining (clinical and/or electromyographic and/or manometric evidence is acceptable).
• Absence of organic abnormalities of the colon on barium enema or on total colonoscopic examination. This criterion was amended to: "If complaints of constipation were of recent onset,i.e., had been present for 6 months to 1 year, results of a colonoscopic examination performed within the last 12 months were needed. If complaints of constipation had been present for more than one year, results of an endoscopic examination performed within the past three years were acceptable".
• Poor results with laxative treatment and diet counselling.
• Constipation of a functional, i.e., idiopathic nature.
• Availability of the patient's written informed consent.
• Patient available for follow-up during the trial period as determined in the protocol.

You may not qualify if:

• Constipation thought to be drug-induced.
• Presence of secondary causes of constipation, for instance: endocrine disorders, metabolic disorders, neurologic disorders.
• Congenital megacolon/megarectum.
• History of previous abdominal surgery other than hysterectomy, surgery for Meckel's diverticle,appendicectomy, cholecystectomy, inguinal repair, splenectomy, nephrectomy or fundoplication.
• Known or suspected organic disorders of the large bowel, i.e., obstruction, carcinoma or inflammatory bowel disease.
• Active proctological conditions which were thought to be responsible for constipation.
• Evidence of a non-relaxing pelvic floor ("anismus") as the main cause of constipation.
• Clinically significant ECG abnormalities.
• Known illnesses or conditions which might interfere in any way with the adequate assessment of the drug under study, such as severe cardiovascular or lung disease, neurologic or psychiatric disorders, alcoholism, cancer or AIDS.
• 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 upper limit of normal.
• Clinically significant abnormalities of blood chemistry, haematology or urinalysis at selection.
• Pregnancy or wish to become pregnant during the course of the study. - Breast feeding.
• Investigational drug received in the 30 days preceding the trial.
• Known use of street drugs e.g., marijuana, cocaine etc.

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

• Marc Van Outryve, MD

  Jan Palfijn 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: February 18, 2008
• Study Start: March 1, 1995
• Primary Completion: March 1, 1996
• Study Completion: March 1, 1996
• Last Updated: May 29, 2008

Record last verified: 2008-02