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

Sucampo

Status and phase

Completed

Phase 3

Conditions

Irritable Bowel Syndrome With Constipation

Treatments

Drug: Lubiprostone

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00380250

0211SIB-0431

Details and patient eligibility

About

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.

Enrollment

590 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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