An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation

NCT ID: NCT01116206

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-03-31

Brief Summary

The purpose of this study is to compare the efficacy and safety of prucalopride to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in treatment of participants with chronic (very serious, life threatening) constipation (decreased number of or difficulty making bowel [the intestine] movements).

Detailed Description

This is a randomized (study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participants receives), placebo-controlled, multi-center (when more than 1 hospital or medical school team work on a medical research study) study with a parallel-group design (a medical research study comparing the response in 2 or more groups of participants receiving different treatments) study of prucalopride. This study consist of 3 phases: a 2 weeks drug-free screening or run in phase, a 12-week treatment phase and follow-up (post-treatment) phase performed 7 days following the last dose of study drug. The total duration of study will be approximately 15 to 20 weeks, including the run-in and post-treatment phases. During the run-in phase, participants will receive laxative (bisacodyl) as a rescue medication throughout the study, if they will not have bowel movement (BM) for 3 or more consecutive days. If participants will not be able to tolerate bisacodyl, an enema may be used in place of the bisacodyl. During the double-blind treatment phase, participants will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups to receive either 2 milligram (mg) prucalopride or matching placebo prucalopride for 12 weeks, orally once daily. Participants will be primarily assessed for spontaneous complete bowel movements (SCBMs) per week. Participant's safety and quality of life will be monitored throughout the study.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prucalopride

prucalopride 2- milligram (mg), orally once daily for 12 weeks

Group Type: EXPERIMENTAL

Prucalopride

Intervention Type: DRUG

2 mg tablet, orally once daily, for 12 weeks

Placebo

Matching placebo, orally once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 tablet, orally once dailyfor 12 weeks

Interventions

Prucalopride

2 mg tablet, orally once daily, for 12 weeks

Intervention Type: DRUG

Placebo

1 tablet, orally once dailyfor 12 weeks

Intervention Type: DRUG

Other Intervention Names

Resolor

Eligibility Criteria

Inclusion Criteria

• History of chronic constipation, defined as on average, 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of the following for at least a quarter of the time for the last 3 months, while symptom onset was more than 6 months before the screening visit: in more than 25 percent (%) of BMs, participants had very hard (little balls) and/or hard stools, sensation of incomplete evacuation, straining at defecation (making a bowel movement), sensation of ano-rectal obstruction or blockade, and/or need for digital manipulation to facilitate evacuation
• Participants who were considered as constipated (who never had SBMs)
• Participant's constipation is functional
• Participants with the diagnosis of irritable bowel syndrome (bowel disorder in which there is pain and diarrhea or constipation) with constipation and with no other organic diseases can potentially be included depending on the decision of the investigator
• Female participants must be postmenopausal (for at least 1 year) or surgically sterile or practicing a highly effective method of birth control

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 (type of cancer), or inflammatory bowel disease)
• - Participants Using or intending to use disallowed medications that may influence the bowel habit during the study
• Participants with severe (very serious, life threatening) and clinically uncontrolled cardiovascular, liver, or lung disease, neurologic or psychiatric disorders (including active alcohol or drug abuse), cancer (abnormal tissue that grows and spreads in the body until it kills) or acquired immune deficiency syndrome (AIDS: illness that results in decreased ability of the body to protect itself from other illnesses; development of the disease or conditions associated with the disease results from Human Immunodeficiency Virus [HIV]), or other gastrointestinal or endocrine disorders
• Participants with impaired renal function, that is, serum creatinine greater than 2 milligram per deciliter (greater than 180 micro mole per liter)
• Participants with clinically significant abnormalities of hematology, urinalysis, or blood chemistry

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Adelaide, , Australia

Box Hill, , Australia

Kingswood, , Australia

Kogarah, , Australia

Newcastle, , Australia

Parkville, , Australia

Prahran, , Australia

Sydney, , Australia

Beijing, , China

Chongqing, , China

Guangzhou, , China

Hangzhou, , China

Hefei, , China

Jinan, , China

Nanjing, , China

Shanghai, , China

Wuhan, , China

Xi'an, , China

Busan, , South Korea

Daegu, , South Korea

Deajun, , South Korea

Gwangju, , South Korea

Iksan, , South Korea

Seoul, , South Korea

Taipei, , Taiwan

Bamgkok, , Thailand

Bangkok, , Thailand

Countries

Australia; China; South Korea; Taiwan; Thailand

References

Lembo A, Staller K, Boules M, Feuerstadt P, Spalding W, Gabriel A, Youssef A, Xie Y, Terreri B, Cash BD. Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies. Therap Adv Gastroenterol. 2024 Dec 10;17:17562848241299731. doi: 10.1177/17562848241299731. eCollection 2024.

Reference Type: DERIVED

PMID: 39664231 (View on PubMed)

Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.

Reference Type: DERIVED

PMID: 34585675 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=852&filename=CR017173_CSR.pdf

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

Other Identifiers

PRUCRC3001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CR017173

Identifier Type: -

Identifier Source: org_study_id