Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

NCT00399542

Irritable Bowel Syndrome Constipation

COMPLETED PHASE3

Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

NCT02544152

Irritable Bowel Syndrome

TERMINATED PHASE2

Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)

NCT01085643

Constipation-predominant Irritable Bowel Syndrome

COMPLETED NA

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation

NCT01162863

Irritable Bowel Syndrome Constipation

COMPLETED NA

Lubiprostone Effects on Visceral Pain Sensitivity

NCT01166789

Irritable Bowel Syndrome

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome With Constipation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lubiprostone

8 mcg capsule twice daily (BID)

Group Type EXPERIMENTAL

Lubiprostone

Intervention Type DRUG

Placebo

Matching placebo capsule twice daily (BID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lubiprostone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age and older
* Stable fiber therapy
* Normal colonoscopy/sigmoidoscopy
* Able to refrain from use of medications known to treat or associated with constipation symptoms
* Experiences abdominal discomfort/pain associated with bowel movements
* Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria

* Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
* Open gastrointestinal or abdominal surgery prior to IBS onset
* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No