A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Subjects With Chronic Constipation

• Register: ClinicalTrials.gov
• Last refreshed on: 5 November 2012
• Main ID: NCT01116206
• Date of registration: 03/05/2010
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Subjects With Chronic Constipation
• Scientific title: Pan-Asia Resolor Trial in Chronic Constipation
• Date of first enrolment: March 2010
• Target sample size: 507
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01116206
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Australia, China, Korea, Republic of, Taiwan, Thailand

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and non-pregnant, non breast-feeding female outpatients

- History of chronic constipation, not satisfied with laxatives: the patient reports,
on average 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of
the following for at least 6 months before the screening visit and during the run-in
phase:a) very hard (little balls) and/or hard stools in more than 25% of BMs

- b) sensation of incomplete evacuation in more than 25% of BMs

- c) straining at defecation in more than 25% of BMs d) sensation of ano-rectal
obstruction or blockade in more than 25% of BMs : e) a need for digital manipulation
to facilitate evacuation in more than 25% of BM

Exclusion Criteria:

- Secondary to other diseases/conditions (endocrine disorders, metabolic disorders or
neurologic disorders or drug-induced or suspected organic disorders of the large
bowel, i.e., obstruction, carcinoma, or inflammatory bowel disease)

- Patients who have polyps discovered on the colonoscopy that are untreated (i.e., by
polypectomy)

- Use of or intent to use disallowed medications that influence the bowel habit during
the study (i.e., anticholinergics [not including antihistamines], opioids,
spasmolytics, prokinetics, and tricyclic antidepressants

- Have severe and clinically uncontrolled cardiovascular, liver, or lung disease,
neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer
or acquired immune deficiency syndrome (AIDS), or other gastrointestinal or endocrine
disorders

- Patients with impaired renal function, i.e., serum creatinine >2 mg/dL (>180 mmol/L)

- Patients with clinically significant abnormalities of hematology, urinalysis, or
blood chemistry

- Known allergies, hypersensitivity, or intolerance to prucalopride or its excipients

- Females of child-bearing potential without adequate contraceptive protection during
the trial

- Patients who have received an investigational drug or used an investigational medical
device in the 30 days preceding the screening visit



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Constipation

Intervention(s)

Drug: placebo

Drug: prucalopride 2-mg

Primary Outcome(s)

The percentage of patients with weekly average of three or more spontaneous, complete bowel movements (SCBM) during the 12-weeks treatment period [Time Frame: 12 weeks]

Secondary Outcome(s)

Average number of SCBMs, spontaneous bowel movements (SBMs) and BMs per week after medication [Time Frame: 12 weeks]

Changes of adverse events, laboratory parameters, vital signs, and electrocardiogram (ECG) data [Time Frame: 12 weeks]

Percentage of patients with change of >1 SCBM/week [Time Frame: 12 weeks]

The percentage of patients with a weekly average of 3 or more SCBMs during the first 4 weeks of the double blind treatment period [Time Frame: 4 weeks]

Time to first SBM [Time Frame: 12 weeks]

Secondary ID(s)

CR017173

Source(s) of Monetary Support

Please refer to primary and secondary sponsors