Irritable Bowel Syndrome Clinical Trial
Official title:
Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
NCT number | NCT00399542 |
Other study ID # | 0211SIB-0432 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | May 2005 |
Est. completion date | July 2006 |
Verified date | September 2013 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 581 |
Est. completion date | July 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sucampo Pharma Americas, LLC | Sucampo Pharmaceuticals, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Month 1 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days | |
Secondary | Month 1 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days | |
Secondary | Month 1 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 1 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Month 1 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 2 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 3 Abdominal Pain Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 1 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 2 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 3 Abdominal Bloating Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 2 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days | |
Secondary | Month 3 Spontaneous Bowel Movement Rates Change From Baseline | Any bowel movement not associated with rescue medication use | 28 days | |
Secondary | Month 2 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days | |
Secondary | Month 3 Stool Consistency Change From Baseline | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) | 28 days | |
Secondary | Month 2 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 3 Bowel Straining Change From Baseline | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 2 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | Month 3 Constipation Severity Change From Baseline | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe | 28 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Month 1 Bowel Movement Rates Change From Baseline | 28 days | ||
Secondary | Month 2 Bowel Movement Rates Change From Baseline | 28 days | ||
Secondary | Month 3 Bowel Movement Rates Change From Baseline | 28 days |
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