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Clinical Trials/NCT00399542
NCT00399542CompletedPhase 3

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 sites581 target enrollmentStarted: May 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
581
Primary Endpoint
Overall Responder Status
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 & constipation cycling) 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

Outcomes

Primary Outcomes

Overall Responder Status

Time Frame: 12 weeks

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

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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