Clinical trial NCT00380250: Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome With Constipation
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Takeda
First posted: 2006-09-25
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Overall Responder Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline
timeFrame: Change from baseline for month 1
measure: Month 1 Stool Consistency Change From Baseline
timeFrame: Change from baseline for month 1
measure: Month 1 Bowel Straining Change From Baseline
timeFrame: Change from baseline for month 1
measure: Month 1 Constipation Severity Change From Baseline
timeFrame: Change from baseline at 28 days
measure: Month 1 Symptom Relief
timeFrame: Change from baseline for month 1
measure: Quality of Life Change From Baseline
timeFrame: Change from baseline at 12 weeks
measure: Month 2 Responder Rate
timeFrame: month 2 (28 days)
measure: Month 3 Responder Rate
timeFrame: month 3 (28 days)
measure: Month 1 Responder Rate
timeFrame: month 1 (28 days)
measure: Month 2 Abdominal Bloating Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Abdominal Bloating Change From Baseline
timeFrame: Change from baseline for month 3
measure: Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline
timeFrame: Change from baseline for month 3
measure: Month 2 Stool Consistency Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Stool Consistency Change From Baseline
timeFrame: Change from baseline for month 3
measure: Month 2 Bowel Straining Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Bowel Straining Change From Baseline
timeFrame: Change from baseline for month 3
measure: Month 2 Constipation Severity Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Constipation Severity Change From Baseline
timeFrame: Change from baseline for month 3
measure: Month 2 Symptom Relief
timeFrame: Change from baseline for month 2
measure: Month 3 Symptom Relief
timeFrame: Change from baseline for month 3
measure: Month 1 Abdominal Bloating Change From Baseline
timeFrame: Change from baseline for month 1
measure: Month 1 Bowel Movement Frequency Rates Change From Baseline
timeFrame: Change from baseline for month 1
measure: Month 2 Bowel Movement Frequency Rates Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Bowel Movement Frequency Rates Change From Baseline
timeFrame: Change from baseline for month 3
measure: Month 1 Abdominal Pain Change From Baseline
timeFrame: Change from baseline for month 1
measure: Month 2 Abdominal Pain Change From Baseline
timeFrame: Change from baseline for month 2
measure: Month 3 Abdominal Pain Change From Baseline
timeFrame: Change from baseline for month 3
Other outcomes:
Locations:
Study officials:
affiliation: Sucampo Pharmaceuticals, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4.