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Clinical Trials/NCT00399542
NCT00399542
Completed
Phase 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 enrollmentMay 2005
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ConditionsIrritable Bowel SyndromeConstipation
DrugsLubiprostonePlacebo

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
Sucampo Pharma Americas, LLC
Enrollment
581
Primary Endpoint
Overall Responder Status
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar 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

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 \& 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)

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