Phase 3
Completed N=590
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Irritable Bowel Syndrome With Constipation
Source: ClinicalTrials.gov NCT00380250 ↗
Enrolled (actual)
590
Serious AEs
1.2%
Results posted
Feb 2014
Primary outcomePrimary: Overall Responder Rate — 13.8; 7.8 percentage of participants — p=0.029
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Responder Rate |
13.8; 7.8 | 0.029 sig |
| SECONDARY Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline |
1.54; 1.21 | 0.117 |
| SECONDARY Month 1 Stool Consistency Change From Baseline |
-0.51; -0.33 | 0.006 sig |
| SECONDARY Month 1 Bowel Straining Change From Baseline |
-0.53; -0.36 | 0.050 |
| SECONDARY Month 1 Constipation Severity Change From Baseline |
-0.41; -0.29 | 0.159 |
| SECONDARY Month 1 Symptom Relief |
0.66; 0.57 | 0.378 |
| SECONDARY Quality of Life Change From Baseline |
16.7; 16.8 | 0.588 |
| SECONDARY Month 2 Responder Rate |
15.9; 9.3 | 0.028 sig |
| SECONDARY Month 3 Responder Rate |
15.9; 10.4 | 0.069 |
| SECONDARY Month 1 Responder Rate |
10.0; 6.2 | 0.098 |
| SECONDARY Month 2 Abdominal Bloating Change From Baseline |
-0.42; -0.35 | 0.286 |
| SECONDARY Month 3 Abdominal Bloating Change From Baseline |
-0.43; -0.37 | 0.337 |
| SECONDARY Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline |
1.59; 1.41 | 0.334 |
| SECONDARY Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline |
1.51; 1.39 | 0.242 |
| SECONDARY Month 2 Stool Consistency Change From Baseline |
-0.53; -0.38 | 0.030 sig |
| SECONDARY Month 3 Stool Consistency Change From Baseline |
-0.52; -0.41 | 0.130 |
| SECONDARY Month 2 Bowel Straining Change From Baseline |
-0.58; -0.43 | 0.049 sig |
| SECONDARY Month 3 Bowel Straining Change From Baseline |
-0.56; -0.45 | 0.348 |
| SECONDARY Month 2 Constipation Severity Change From Baseline |
-0.50; -0.40 | 0.064 |
| SECONDARY Month 3 Constipation Severity Change From Baseline |
-0.51; -0.41 | 0.111 |
| SECONDARY Month 2 Symptom Relief |
0.76; 0.59 | 0.144 |
| SECONDARY Month 3 Symptom Relief |
0.74; 0.57 | 0.168 |
| SECONDARY Month 1 Abdominal Bloating Change From Baseline |
-0.30; -0.24 | 0.615 |
| SECONDARY Month 1 Bowel Movement Frequency Rates Change From Baseline |
1.22; 0.88 | 0.108 |
| SECONDARY Month 2 Bowel Movement Frequency Rates Change From Baseline |
1.23; 1.10 | 0.483 |
| SECONDARY Month 3 Bowel Movement Frequency Rates Change From Baseline |
1.15; 1.04 | 0.491 |
| SECONDARY Month 1 Abdominal Pain Change From Baseline |
-0.29; -0.27 | <0.001 sig |
| SECONDARY Month 2 Abdominal Pain Change From Baseline |
-0.43; -0.37 | <0.001 sig |
| SECONDARY Month 3 Abdominal Pain Change From Baseline |
-0.42; -0.36 | <0.001 sig |
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 and constipation cycling) irritable bowel syndrome (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 (NCT00380250). 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. Informational only — not medical advice.