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

Sucampo Pharma Americas, LLC590 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

590

Conditions

Irritable Bowel Syndrome With Constipation

Interventions

LubiprostoneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Responder Rate

Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months

Time frame: 12 weeks

Secondary Outcomes

Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline

SBMs are any bowel movement not associated with rescue medication use.

Time frame: Change from baseline for month 1

Month 1 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

Time frame: Change from baseline for month 1

Month 1 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 1

Month 1 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline at 28 days

Month 1 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

Time frame: Change from baseline for month 1

Quality of Life Change From Baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Irritable Bowel Syndrome Quality of Life (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

Time frame: Change from baseline at 12 weeks

Month 2 Responder Rate

Time frame: month 2 (28 days)

Month 3 Responder Rate

Symptoms \>= Moderately relieved for 4 weeks/month or Significantly relieved for \>=2 weeks/month AND: 1. Rescue medication use does not increase during the month as compared to baseline; 2. No discontinuation during the month due to lack of efficacy;AND 3. No ratings during the month of Moderately worse or Significantly worse.

Time frame: month 3 (28 days)

Month 1 Responder Rate

Time frame: month 1 (28 days)

Month 2 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 2

Month 3 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 3

Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Time frame: Change from baseline for month 2

Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Time frame: Change from baseline for month 3

Month 2 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

Time frame: Change from baseline for month 2

Month 3 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

Time frame: Change from baseline for month 3

Month 2 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 2

Month 3 Bowel Straining Change From Baseline

0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 3

Month 2 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 2

Month 3 Constipation Severity Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 3

Month 2 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

Time frame: Change from baseline for month 2

Month 3 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

Time frame: Change from baseline for month 3

Month 1 Abdominal Bloating Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 1

Month 1 Bowel Movement Frequency Rates Change From Baseline

Time frame: Change from baseline for month 1

Month 2 Bowel Movement Frequency Rates Change From Baseline

Time frame: Change from baseline for month 2

Month 3 Bowel Movement Frequency Rates Change From Baseline

Time frame: Change from baseline for month 3

Month 1 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 1

Month 2 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 2

Month 3 Abdominal Pain Change From Baseline

0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

Time frame: Change from baseline for month 3