NCT00575614

Brief Summary

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic idiopathic constipation. Hypothesis: Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic constipation shows a favourable effect on most of the efficacy parameters assessed in this trial. This dosage can be considered safe and generally well-tolerated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 1997

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1999

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

May 29, 2008

Status Verified

December 1, 2007

Enrollment Period

1.9 years

First QC Date

December 17, 2007

Last Update Submit

May 28, 2008

Conditions

Constipation

Keywords

ConstipationPrucaloprideAno-rectal physiologyOro-caecal transit timeQOL

Outcome Measures

Primary Outcomes (1)

  • Whole gut transit

    4 weeks

Secondary Outcomes (1)

  • Ano-rectal physiology

    4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: prucalopride

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

prucaloprideDRUG

1 mg o.d.

Also known as: Resolor
1
placeboDRUG

o.d.

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female subjects of 18 years or over;
  • history of chronic constipation during at least 6 months before selection, characterized by either two or fewer spontaneous (ie, without using laxatives) bowel movements in a week or straining at defaecation at least a quarter of the time;
  • written informed consent;
  • within 20% of her body weight as specified in the Metropolitan Life Insurance Company's 1983 Height and Weight Table2;
  • healthy on the basis of a pre-trial physical examination, medical history, anamnesis,electrocardiogram and the results of biochemistry, haematology and urinalysis, carried out within 3 weeks of randomization. If the results of the laboratory tests were not within the reference ranges, the subject could only be included on condition that the investigator did not judge the deviations to be clinically relevant.

You may not qualify if:

  • use of disallowed concomitant medication;
  • subjects who had undergone surgery for their constipation;
  • subjects with faecal impaction;
  • subjects suffering from different types or causes of constipation other than idiopathic constipation, ie, presence of secondary causes, eg, endocrine disorders, metabolic disorders, neurologic disorders;
  • subjects with a megacolon/megarectum;
  • subjects with external rectal prolapse;
  • 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, ie, obstruction, carcinoma or inflammatory bowel disease. If complaints of constipation were of recent onset, ie, had been present for less than one year, and the subject was 40 years or older, results of a Ba-enema or of colonoscopic examination were required;
  • subjects with solitary rectal ulcer (this had to be excluded by rigid sigmoidoscopic examination at the first visit);
  • subjects with active proctological conditions thought to be responsible for the constipation;
  • subjects with known illnesses or conditions such as: severe cardiovascular or lung disease, neurologic or psychiatric disorders (including substance abuse/dependence, but with the exception of nicotine), alcoholism, cancer or AIDS and other gastrointestinal or endocrine disorders;
  • subjects receiving, or who had received, care for an eating disorder;
  • subjects with impaired renal function;
  • subjects with a serum amylase, a serum glutamic-oxaloacetic transaminase (SGOT), or a serum glutamic-pyruvic transaminase (SGPT) concentration of \> 2 times the normal limit;
  • pregnancy or wish to become pregnant in the course of the trial. Lack of an acceptable birth control method;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Emmanuel AV, Roy AJ, Nicholls TJ, Kamm MA. Prucalopride, a systemic enterokinetic, for the treatment of constipation. Aliment Pharmacol Ther. 2002 Jul;16(7):1347-56. doi: 10.1046/j.1365-2036.2002.01272.x.

    PMID: 12144586RESULT

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Kamm, MD

    Northwick Park 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

December 17, 2007

First Posted

December 18, 2007

Study Start

April 1, 1997

Primary Completion

March 1, 1999

Study Completion

March 1, 1999

Last Updated

May 29, 2008

Record last verified: 2007-12