NCT02228616

Brief Summary

The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel movements (SCBMs) (responders) during the 12-week treatment phase as compared to the baseline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 14, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2016

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 26, 2014

Last Update Submit

September 14, 2017

Conditions

Constipation

Keywords

ConstipationChronic constipationPrucaloprideWomen

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline

    12 weeks

Secondary Outcomes (10)

  • Percentage of subjects with a weekly 3 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline

    12 weeks

  • Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the first 4 weeks treatment phase as compared to the baseline

    4 weeks

  • Percentage of subjects with a weekly average increase of 1 or more Spontaneous Bowel Movement (SBM), Bowel Movement (BM) during the 12-week treatment phase as compared to the baseline

    12 weeks

  • Average number of Spontaneous Complete Bowel Movement (SCBM) per week

    12 weeks

  • Average number of SBMs per week

    12 weeks

  • +5 more secondary outcomes

Study Arms (1)

Prucalopride plus Polyethylene glycol or lactulose

EXPERIMENTAL
Drug: PrucaloprideDrug: Polyethylene glycol (PEG)Drug: Lactulose

Interventions

PrucaloprideDRUG

During the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast.

Prucalopride plus Polyethylene glycol or lactulose
Polyethylene glycol (PEG)DRUG

Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).

Prucalopride plus Polyethylene glycol or lactulose
LactuloseDRUG

Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).

Prucalopride plus Polyethylene glycol or lactulose

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 to 65 years, inclusive
  • History of chronic constipation (CC): The subject reports, a weekly average of 2 or fewer spontaneous bowel movement (SBMs) and 1 or more of the following within the preceding 3 months before the screening visit, while symptom onset was more than 6 months before the screening visit: 1. very hard (little balls) and/or hard stools in more than 25% of BMs; 2. sensation of incomplete evacuation in more than 25% of BMs; 3. straining at defecation in more than 25% of BMs; 4. sensation of a no-rectal obstruction or blockade in more than 25% of BMs; 5. A need for digital manipulation to facilitate evacuation in more than 25% of BMs
  • Subjects who has been using PEG or lactulose treatment for more than 1 week at screening
  • Be a non-pregnant, non-lactating woman. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Women must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test immediately prior to study drug titration
  • Subject had NO SBMs during the run-in phase is considered to be constipated

You may not qualify if:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study
  • Subjects in whom constipation is thought to be drug-induced
  • Subjects suffering from secondary causes of CC
  • Use of or intent to use disallowed medications that influence the bowel habit during the study (ie, anticholinergics \[not including antihistamines\], opioids, spasmolytics, prokinetics, and tricyclic antidepressants)
  • Subjects with 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
  • Subjects with impaired renal function, i.e., serum creatinine \>2 milligram/deciliter(\>180 micromole/Liter)
  • Subjects with clinically significant abnormalities of hematology, urinalysis, or blood chemistry
  • Known allergies, hypersensitivity, or intolerance to prucalopride or its excipients
  • Women who are pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Beijing, China

Location

Unknown Facility

Binzhou, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Wuhan, China

Location

Unknown Facility

Zhengzhou, China

Location

Related Links

MeSH Terms

Conditions

Constipation

Interventions

prucalopridePolyethylene GlycolsLactulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

    Xian-Janssen Pharmaceutical Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 29, 2014

Study Start

October 14, 2014

Primary Completion

September 28, 2016

Study Completion

September 28, 2016

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

CN(9)