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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01116206
First received: May 3, 2010
Last updated: October 28, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to compare the efficacy and safety of prucalopride 2 mg given orally once daily for 12 weeks to those of placebo in treatment of chronic constipation. Prucalopride is an investigational drug that is being tested to see if it may be useful in treating chronic constipation.


Condition Intervention Phase
Constipation
Drug: prucalopride 2-mg
Drug: placebo
Phase 3

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
Official Title: Pan-Asia Resolor Trial in Chronic Constipation

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of patients with change of >1 SCBM/week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Average number of SCBMs, spontaneous bowel movements (SBMs) and BMs per week after medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to first SBM [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes of adverse events, laboratory parameters, vital signs, and electrocardiogram (ECG) data [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 507
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
prucalopride 2-mg 2mg tablet once daily for 12 weeks
Drug: prucalopride 2-mg
2mg tablet once daily for 12 weeks
Placebo Comparator: 002
placebo 1 tablet once daily for 12 weeks
Drug: placebo
1 tablet once daily for 12 weeks

Detailed Description:

Prucalopride is new potent, selective and specific serotonin 4 receptor agonist that stimulates the bowel motility. It is being investigated to see if it may be useful in treating chronic constipation. This study will compare the efficacy and safety of prucalopride 2-mg given orally once daily for 12 weeks to those of placebo in the treatment of chronic constipation. Placebo looks like the drug being studied but has no active ingredients. This study consists of 3 phases: a 2-week drug-free screening phase, a 12-week treatment phase, and a posttreatment follow-up contact performed 7 days following the last dose of study drug. The total duration of the patient's participation in the study is approximately 15 weeks. During the screening phase, the patient's bowel habit will be documented and the existence of chronic constipation confirmed. At the start of this phase, all existing laxative medication will be withdrawn and patient will be instructed not to change their diet or lifestyle during the study. Patients will be allowed to take a laxative (bisacodyl) as a rescue medication throughout the trial, but only if they have not had a bowel movement (BM) for three or more consecutive days. No bisacodyl should be taken or enemas used within 48 hours prior to the start of the double-blind treatment (48 hours prior to Day1) and 48 hours following the start of double-blind treatment (48 hours following Day1). The patient will enter the double-blind treatment phase if constipation is shown to be present during the screening phase. If the definition of constipation is not met during the screening period, the patient will be considered ineligible and will be discontinued from the study. During the double-blind treatment phase, the patient will be treated for 12 weeks with 2-mg prucalopride or matching placebo, given orally once daily before breakfast. Patients will record study drug and rescue medication dosing information and information related to bowel movements in a daily diary throughout the study. 2-mg Prucalopride/placebo tablet, given orally once daily for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116206

Locations
Australia
Adelaide, Australia
Box Hill, Australia
Kingswood, Australia
Kogarah, Australia
Newcastle, Australia
Parkville, Australia
Prahran, Australia
Sydney, Australia
China
Beijing, China
Chongqing, China
Guangzhou, China
Hangzhou, China
Hefei, China
Jinan, China
Nanjing, China
Shanghai, China
Wuhan, China
Xian, China
Korea, Republic of
Dae-Gu, Korea, Republic of
Deajun, Korea, Republic of
Gwangju, Korea, Republic of
Iksan, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Taipei, Taiwan
Thailand
Bamgkok, Thailand
Bangkok, Thailand
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Clinical Leader, Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01116206     History of Changes
Other Study ID Numbers: CR017173
Study First Received: May 3, 2010
Last Updated: October 28, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Resolor
Prucalopride

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014