Clinical trial NCT01116206: An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation
Official title: A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prucalopride (Resolor) Tablets in Participants With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Keywords: Constipation
Prucalopride
Resolor
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With an Average of 3 or More Spontaneous Complete Bowel Movements (SCBMs)
timeFrame: Week 1 to 12
Secondary outcomes:
measure: Percentage of Participants With an Average of 3 or More SCBMs During the First 4 Weeks
timeFrame: Week 1 to 4
measure: Percentage of Participants With an Average Increase of 1 or More Bowel Movements (BMs)
timeFrame: Week 1 to 12
measure: Percentage of Participants With an Average of 3 or More SCBMs During Weeks 5 to 8 and 9 to 12
timeFrame: Week 5 to Week 8 and Week 9 to Week 12
measure: Average Number of SCBMs
timeFrame: Week 1 to 12
measure: Average Number of Spontaneous Bowel Movements (SBMs)
timeFrame: Week 1 to 12
measure: Average Number of all Bowel Movements (BMs)
timeFrame: Week 1 to 12
measure: Time-to-First SCBM and Time-to-First Week With 3 or More SCBMs After the First Dose of the Study Drug
timeFrame: Week 1 to 12
measure: Average Number of Bisacodyl Tablets
timeFrame: Week 1 to 12
measure: Percentage of Participants With Zero, Less Than (<) 2 and Greater Than and Equal to (>=) 2 Tablets of Bisacodyl Taken
timeFrame: Week 1 to 12
measure: Percentage of BMs With Normal Consistency
timeFrame: Week 1 to 12
measure: Percentage of BMs With Less Straining
timeFrame: Week 1 to 12
measure: Percentage of BMs with a Sensation of Complete Evacuation
timeFrame: Week 1 to 12
measure: Participants Global Assessment on Consistency of Stool
timeFrame: Week 2, 4, 8 and 12
measure: Participants Global Assessment on Severity of Constipation
timeFrame: Week 2, Week 4, Week 8 and Week 12
measure: Participants Global Assessment on Efficacy of Treatment
timeFrame: Week 2, Week 4, Week 8, and Week 12
measure: Investigator's Global Assessment on Efficacy of Treatment
timeFrame: Week 4 and 12
measure: Change From Baseline in Patient Assessment of Constipation-Symptom Questionnaire (PAC-SYM) Total Score at Week 2, 4, 8 and 12
timeFrame: Baseline, Week 2, 4, 8, and 12
measure: Change From Baseline in the PAC-SYM Subscale Scores at Week 2, 4, 8 and 12
timeFrame: Baseline, Week 2, 4, 8, and 12
measure: Percentage of Participant's who Rated Study Drug effectiveness
timeFrame: Week 2, Week 4, Week 8 and Week 12
measure: Percentage of Participants With PAC SYM Score
timeFrame: Weeks 2, 4, 8, and 12
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 13
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: Baseline up to Week 12
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Week 12
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 12
Locations:
city: Adelaide
country: Australia
city: Box Hill
country: Australia
city: Kingswood
country: Australia
city: Kogarah
country: Australia
city: Newcastle
country: Australia
city: Parkville
country: Australia
city: Prahran
country: Australia
city: Sydney
country: Australia
city: Beijing
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hefei
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Wuhan
country: China
city: Xian
country: China
city: Busan
country: Korea, Republic of
city: Dae-Gu
country: Korea, Republic of
city: Deajun
country: Korea, Republic of
city: Gwangju-Si
country: Korea, Republic of
city: Iksan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Taipei
country: Taiwan
city: Bamgkok
country: Thailand
city: Bangkok
country: Thailand
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.