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

Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome; Constipation
• Intervention / Treatment: Drug: Placebo; Drug: Lubiprostone

• Study Type: Interventional
• Enrollment (Actual): 581
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Month 1 Spontaneous Bowel Movement Rates Change From Baseline	Any bowel movement not associated with rescue medication use	28 days
Month 1 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	28 days
Month 1 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 1 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
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
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
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
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
Month 1 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 2 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 3 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 1 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 2 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 3 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 2 Spontaneous Bowel Movement Rates Change From Baseline	Any bowel movement not associated with rescue medication use	28 days
Month 3 Spontaneous Bowel Movement Rates Change From Baseline	Any bowel movement not associated with rescue medication use	28 days
Month 2 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	28 days
Month 3 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	28 days
Month 2 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 3 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 2 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Month 3 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
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
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
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
Month 1 Bowel Movement Rates Change From Baseline		28 days
Month 2 Bowel Movement Rates Change From Baseline		28 days
Month 3 Bowel Movement Rates Change From Baseline		28 days

Collaborators and Investigators

• Sponsor: Sucampo Pharma Americas, LLC
• Collaborators: Sucampo Pharmaceuticals, Inc.
• Investigators: Study Director: Medical Monitor, MD, Sucampo Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (ACTUAL): July 1, 2006
• Study Completion (ACTUAL): July 1, 2006

Study Registration Dates

• First Submitted: November 13, 2006
• First Submitted That Met QC Criteria: November 14, 2006
• First Posted (ESTIMATE): November 15, 2006

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome With Constipation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: 0211SIB-0432