- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399542
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Month 1 Spontaneous Bowel Movement Rates Change From Baseline
Time Frame: 28 days
|
Any bowel movement not associated with rescue medication use
|
28 days
|
Month 1 Stool Consistency Change From Baseline
Time Frame: 28 days
|
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
|
28 days
|
Month 1 Bowel Straining Change From Baseline
Time Frame: 28 days
|
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 1 Constipation Severity Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 1 Symptom Relief
Time Frame: 28 days
|
|
28 days
|
Month 1 Responder Rate
Time Frame: 28 days
|
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
Time Frame: 28 days
|
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
Time Frame: 28 days
|
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
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 2 Abdominal Pain Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 3 Abdominal Pain Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 1 Abdominal Bloating Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 2 Abdominal Bloating Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 3 Abdominal Bloating Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 2 Spontaneous Bowel Movement Rates Change From Baseline
Time Frame: 28 days
|
Any bowel movement not associated with rescue medication use
|
28 days
|
Month 3 Spontaneous Bowel Movement Rates Change From Baseline
Time Frame: 28 days
|
Any bowel movement not associated with rescue medication use
|
28 days
|
Month 2 Stool Consistency Change From Baseline
Time Frame: 28 days
|
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
|
28 days
|
Month 3 Stool Consistency Change From Baseline
Time Frame: 28 days
|
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
|
28 days
|
Month 2 Bowel Straining Change From Baseline
Time Frame: 28 days
|
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 3 Bowel Straining Change From Baseline
Time Frame: 28 days
|
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 2 Constipation Severity Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 3 Constipation Severity Change From Baseline
Time Frame: 28 days
|
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
|
28 days
|
Month 2 Symptom Relief
Time Frame: 28 days
|
|
28 days
|
Month 3 Symptom Relief
Time Frame: 28 days
|
|
28 days
|
Month 3 Quality of Life Change From Baseline
Time Frame: 12 weeks
|
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
Time Frame: 28 days
|
28 days
|
|
Month 2 Bowel Movement Rates Change From Baseline
Time Frame: 28 days
|
28 days
|
|
Month 3 Bowel Movement Rates Change From Baseline
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Monitor, MD, Sucampo Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Constipation
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Chloride Channel Agonists
- Lubiprostone
Other Study ID Numbers
- 0211SIB-0432
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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