Phase 3
N=581
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome · Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00399542 ↗Enrolled (actual)
581
Serious AEs
—
Results posted
Oct 2008
Primary outcome: Primary: Overall Responder Status — 12.1; 5.7 percentage of participants — p=0.023
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sucampo Pharma Americas, LLC
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Responder Status |
12.1; 5.7 | 0.023 sig |
| SECONDARY Month 1 Spontaneous Bowel Movement Rates Change From Baseline |
1.55; 1.29 | 0.391 |
| SECONDARY Month 1 Stool Consistency Change From Baseline |
-0.47; -0.37 | 0.151 |
| SECONDARY Month 1 Bowel Straining Change From Baseline |
-0.54; -0.42 | 0.163 |
| SECONDARY Month 1 Constipation Severity Change From Baseline |
-0.41; -0.33 | 0.185 |
| SECONDARY Month 1 Symptom Relief |
0.69; 0.60 | 0.300 |
| SECONDARY Month 1 Responder Rate |
9.8; 6.8 | 0.303 |
| SECONDARY Month 2 Responder Rate |
16.1; 9.9 | 0.047 sig |
| SECONDARY Month 3 Responder Rate |
13.5; 5.7 | 0.008 sig |
| SECONDARY Month 1 Abdominal Pain Change From Baseline |
-0.32; -0.29 | 0.663 |
| SECONDARY Month 2 Abdominal Pain Change From Baseline |
-0.44; -0.33 | 0.224 |
| SECONDARY Month 3 Abdominal Pain Change From Baseline |
-0.47; -0.35 | 0.271 |
| SECONDARY Month 1 Abdominal Bloating Change From Baseline |
-0.31; -0.28 | 0.945 |
| SECONDARY Month 2 Abdominal Bloating Change From Baseline |
-0.43; -0.33 | 0.352 |
| SECONDARY Month 3 Abdominal Bloating Change From Baseline |
-0.45; -0.35 | 0.180 |
| SECONDARY Month 2 Spontaneous Bowel Movement Rates Change From Baseline |
1.61; 1.39 | 0.275 |
| SECONDARY Month 3 Spontaneous Bowel Movement Rates Change From Baseline |
1.43; 1.42 | 0.722 |
| SECONDARY Month 2 Stool Consistency Change From Baseline |
-0.50; -0.41 | 0.177 |
| SECONDARY Month 3 Stool Consistency Change From Baseline |
-0.49; -0.39 | 0.082 |
| SECONDARY Month 2 Bowel Straining Change From Baseline |
-0.62; -0.50 | 0.110 |
| SECONDARY Month 3 Bowel Straining Change From Baseline |
-0.63; -0.50 | 0.146 |
| SECONDARY Month 2 Constipation Severity Change From Baseline |
-0.51; -0.42 | 0.373 |
| SECONDARY Month 3 Constipation Severity Change From Baseline |
-0.53; -0.42 | 0.339 |
| SECONDARY Month 2 Symptom Relief |
0.79; 0.55 | 0.023 sig |
| SECONDARY Month 3 Symptom Relief |
0.75; 0.56 | 0.073 |
| SECONDARY Month 3 Quality of Life Change From Baseline |
17.3; 13.4 | 0.062 |
| SECONDARY Month 1 Bowel Movement Rates Change From Baseline |
1.30; 0.87 | 0.060 |
| SECONDARY Month 2 Bowel Movement Rates Change From Baseline |
1.29; 0.95 | 0.290 |
| SECONDARY Month 3 Bowel Movement Rates Change From Baseline |
1.17; 0.97 | 0.495 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00399542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.