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

NCT01116206 | Completed Phase 3

• 2 other identifiers: CR017173PRUCRC3001
• Study Type: interventional
• Target: 507
• Locations: 5 countries
• Sites: 27

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).

Conditions

Constipation

Keywords

Constipation; Prucalopride; Resolor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Average of 3 or More Spontaneous Complete Bowel Movements (SCBMs)

  Percentage of responders (responders: participants with an average of 3 or more SCBMs per week) will be assessed during 12-week double-blind treatment phase (total treatment duration). SCBM is defined as a Spontaneous Bowel Movement (SBM) associated with a sense of complete evacuation. SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository used on either the calendar day of the BM or the calendar day before the BM. The total number of SBMs associated with a feeling of complete evacuation will be summed and divided by 12. Average weekly frequency of SCBMs will be calculated as number of SCBMs in treatment phase multiplied by 7 divided by total number of evaluable days in treatment phase.

  Week 1 to 12

Secondary Outcomes (20)

• Percentage of Participants With an Average of 3 or More SCBMs During the First 4 Weeks

  Week 1 to 4

• Percentage of Participants With an Average Increase of 1 or More Bowel Movements (BMs)

  Week 1 to 12

• Percentage of Participants With an Average of 3 or More SCBMs During Weeks 5 to 8 and 9 to 12

  Week 5 to Week 8 and Week 9 to Week 12

• Average Number of SCBMs

  Week 1 to 12

• Average Number of Spontaneous Bowel Movements (SBMs)

  Week 1 to 12

Other Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Week 13

• Number of Participants With Clinically Significant Laboratory Values

  Baseline up to Week 12

• Number of Participants With Clinically Significant Vital Signs Abnormalities

  Baseline up to Week 12

Study Arms (2)

Prucalopride

EXPERIMENTAL

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

Drug: Prucalopride

Placebo

PLACEBO COMPARATOR

Matching placebo, orally once daily for 12 weeks

Drug: Placebo

Interventions

Prucalopride DRUG

2 mg tablet, orally once daily, for 12 weeks

Also known as: Resolor

Prucalopride

Placebo DRUG

1 tablet, orally once dailyfor 12 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (27)

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Adelaide, Australia

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Box Hill, Australia

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Kingswood, Australia

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Kogarah, Australia

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Newcastle, Australia

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Parkville, Australia

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Prahran, Australia

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Sydney, Australia

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Beijing, China

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Chongqing, China

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Guangzhou, China

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Hangzhou, China

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Hefei, China

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Jinan, China

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Nanjing, China

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Shanghai, China

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Wuhan, China

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Xi'an, China

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Busan, South Korea

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Daegu, South Korea

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Deajun, South Korea

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Gwangju, South Korea

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Iksan, South Korea

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Seoul, South Korea

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Taipei, Taiwan

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Bamgkok, Thailand

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Bangkok, Thailand

Location

Related Publications (2)

• 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.

  PMID: 39664231 DERIVED

• 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.

  PMID: 34585675 DERIVED

Related Links

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

MeSH Terms

Conditions

Constipation

Interventions

prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

AU (8); KR (6); TW (1); CN (10); TH (2)