Title
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
Phase
Phase 3Lead Sponsor
SucampoStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Irritable Bowel Syndrome ConstipationIntervention/Treatment
lubiprostone ...Study Participants
581The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
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
| Event Type | Organ System | Event Term | Lubiprostone | Placebo |
|---|
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.
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Any bowel movement not associated with rescue medication use
Any bowel movement not associated with rescue medication use
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Any bowel movement not associated with rescue medication use
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
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.
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.
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.
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
IBS-QOL questionnaire included 34 questions with 5 possible responses yielding the following sub-categories: dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual, and relationship Results range from 34 (low) to 100 (high); meaningful clinical improvement=14 point increase
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
