Phase 3 Completed N=581 Randomized Double-blind Treatment

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

Irritable Bowel Syndrome · chronic constipation

Source: ClinicalTrials.gov NCT00399542 ↗

Enrolled (actual)

581

Serious AEs

—

Results posted

Oct 2008

Primary outcomePrimary: Overall Responder Status — 12.1; 5.7 percentage of participants — p=0.023

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 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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.