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

Study Overview
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Brief Summary
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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.

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

Conditions
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Irritable Bowel Syndrome, Constipation

Intervention / Treatment
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* Drug: Lubiprostone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lubiprostone|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Responder Status | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Month 1 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days | 
| Month 1 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days | 
| Month 1 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 1 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 1 Symptom Relief | 3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved | 28 days | 
| Month 1 Responder Rate | 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. | 28 days | 
| Month 2 Responder Rate | 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. | 28 days | 
| Month 3 Responder Rate | 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. | 28 days | 
| Month 1 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 2 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 3 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 1 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 2 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 3 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 2 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days | 
| Month 3 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days | 
| Month 2 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days | 
| Month 3 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days | 
| Month 2 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 3 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 2 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 3 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | 
| Month 2 Symptom Relief | 3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved | 28 days | 
| Month 3 Symptom Relief | 3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved | 28 days | 
| Month 3 Quality of Life Change From Baseline | 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 | 12 weeks | 
| Month 1 Bowel Movement Rates Change From Baseline |  | 28 days | 
| Month 2 Bowel Movement Rates Change From Baseline |  | 28 days | 
| Month 3 Bowel Movement Rates Change From Baseline |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome With Constipation