Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation

Sucampo Pharma Americas, LLC0 sites590 target enrollmentMay 2005

ConditionsIrritable Bowel Syndrome With Constipation

InterventionsLubiprostone Placebo

DrugsLubiprostone Placebo

Overview

Phase: Phase 3
Intervention: Lubiprostone
Conditions: Irritable Bowel Syndrome With Constipation
Sponsor: Sucampo Pharma Americas, LLC
Enrollment: 590
Primary Endpoint: Overall Responder Rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

July 2006

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sucampo Pharma Americas, LLC

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Lubiprostone

8 mcg capsule twice daily (BID)

Intervention: Lubiprostone

Placebo

Matching placebo capsule twice daily (BID)

Intervention: Placebo

Outcomes

Primary Outcomes

Overall Responder Rate

Time Frame: 12 weeks

Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months

Secondary Outcomes

Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline(Change from baseline for month 1)
Quality of Life Change From Baseline(Change from baseline at 12 weeks)
Month 3 Bowel Straining Change From Baseline(Change from baseline for month 3)
Month 1 Constipation Severity Change From Baseline(Change from baseline at 28 days)
Month 1 Symptom Relief(Change from baseline for month 1)
Month 2 Stool Consistency Change From Baseline(Change from baseline for month 2)
Month 3 Responder Rate(month 3 (28 days))
Month 3 Abdominal Bloating Change From Baseline(Change from baseline for month 3)
Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 2)
Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 3)
Month 1 Bowel Straining Change From Baseline(Change from baseline for month 1)
Month 2 Responder Rate(month 2 (28 days))
Month 2 Abdominal Bloating Change From Baseline(Change from baseline for month 2)
Month 3 Constipation Severity Change From Baseline(Change from baseline for month 3)
Month 1 Stool Consistency Change From Baseline(Change from baseline for month 1)
Month 1 Responder Rate(month 1 (28 days))
Month 3 Stool Consistency Change From Baseline(Change from baseline for month 3)
Month 2 Bowel Straining Change From Baseline(Change from baseline for month 2)
Month 3 Symptom Relief(Change from baseline for month 3)
Month 1 Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 1)
Month 1 Abdominal Pain Change From Baseline(Change from baseline for month 1)
Month 2 Abdominal Pain Change From Baseline(Change from baseline for month 2)
Month 2 Constipation Severity Change From Baseline(Change from baseline for month 2)
Month 2 Symptom Relief(Change from baseline for month 2)
Month 1 Abdominal Bloating Change From Baseline(Change from baseline for month 1)
Month 2 Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 2)
Month 3 Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 3)
Month 3 Abdominal Pain Change From Baseline(Change from baseline for month 3)