Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

NCT00596596 | Completed Phase 2

• 1 other identifier: PRU-USA-3
• Study Type: interventional
• Target: 313
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to determine whether prucalopride is safe and effective in patients with chronic idiopathic constipation. Hypothesis: At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation.

Conditions

Constipation

Keywords

Constipation; prucalopride

Outcome Measures

Primary Outcomes (1)

• Evaluation of the optimal dose of R093877 for the treatment of chronic idiopathic constipation by comparing the efficacy and safety of 0.5 mg, 1 mg, 2 mg, and 4 mg of R093877 versus placebo given orally once daily for 4 weeks.

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (5)

1

ACTIVE COMPARATOR

0,5 mg prucalopride

Drug: prucalopride

2

ACTIVE COMPARATOR

1 mg prucalopride

Drug: prucalopride

3

ACTIVE COMPARATOR

2 mg prucalopride

Drug: 2 mg prucalopride

5

PLACEBO COMPARATOR

Placebo arm

Other: Placebo

4

ACTIVE COMPARATOR

4 mg prucalopride

Drug: 4 mg prucalopride

Interventions

prucalopride DRUG

0,5 mg once daily

Also known as: Resolor

1

2 mg prucalopride DRUG

2 mg once daily

Also known as: Resolor

3

4 mg prucalopride DRUG

4 mg once daily

Also known as: Resolor

4

Placebo OTHER

placebo once daily

5

Eligibility Criteria

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

You may qualify if:

• Male and non-pregnant female outsubjects between 18 and 70 years of age.
• Documented history of constipation. The subject reports 2 or less SCBM/week with the occurrence of one or more of the following for at least 3 months before selection visit:
• 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; or
• straining at defecation at least a quarter of the time.
• These criteria were only applicable for spontaneous, complete bowel movements, i.e., not preceded within a period of 24 hours by the intake of a laxative agent.
• 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).
• The subject's constipation was functional, i.e., idiopathic.
• Written informed consent, signed by the subject and/or legal guardian and by the investigator.
• Subject were available for follow-up during the trial period, as determined in the protocol.

You may not qualify if:

• Subjects in whom constipation was thought to have been drug-induced.
• Subject who suffered from types/causes of constipation other than idiopathic constipation, i.e.,presence of secondary causes of constipation including:
• Endocrine disorders
• Metabolic disorders
• Neurologic disorders including:
• Irritable bowel syndrome.
• Subjects with congenital megacolon/megarectum or a diagnosis or pseudo-obstruction.
• History of previous abdominal surgery (excluding hysterectomy, surgery for Meckel's diverticle,appendectomy, cholecystectomy, inguinal hernia repair, splenectomy, nephrectomy, fundoplication)thought to have been the primary cause of constipation.
• Known or suspected organic disorders of the large bowel (i.e., obstruction, carcinoma, or inflammatory bowel disease). -Subjects with active proctological conditions thought to have been responsible for the constipation.
• Subjects with ECG abnormalities including:
• nd or 3rd degree AV block;
• prolonged QTc intervals (\> 460 msec); or
• bradycardia (\< or equal to 60 bpm).
• Subjects who were receiving concomitant medication which could cause QT prolongation
• Subjects on potassium-wasting diuretics.

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

• Trent Nichols, MD

  Hanover General 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: January 8, 2008
• First Posted: January 17, 2008
• Study Start: September 1, 1996
• Primary Completion: June 1, 1997
• Study Completion: June 1, 1997
• Last Updated: May 29, 2008

Record last verified: 2008-01