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

Primary Purpose

Irritable Bowel Syndrome With Constipation

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Lubiprostone

    Placebo

    Arm Description

    8 mcg capsule twice daily (BID)

    Matching placebo capsule twice daily (BID)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline
    SBMs are any bowel movement not associated with rescue medication use.
    Month 1 Stool Consistency Change From Baseline
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
    Month 1 Bowel Straining Change From Baseline
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 1 Constipation Severity Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    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
    Quality of Life Change From Baseline
    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
    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 during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
    Month 3 Responder Rate
    Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND: Rescue medication use does not increase during the month as compared to baseline; No discontinuation during the month due to lack of efficacy;AND No ratings during the month of Moderately worse or Significantly worse.
    Month 1 Responder Rate
    Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND: Rescue medication use does not increase during the month as compared to baseline; No discontinuation during the month due to lack of efficacy;AND No ratings during the month of Moderately worse or Significantly worse.
    Month 2 Abdominal Bloating Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 3 Abdominal Bloating Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline
    Any bowel movement not associated with rescue medication use
    Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline
    Any bowel movement not associated with rescue medication use
    Month 2 Stool Consistency Change From Baseline
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
    Month 3 Stool Consistency Change From Baseline
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
    Month 2 Bowel Straining Change From Baseline
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 3 Bowel Straining Change From Baseline
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 2 Constipation Severity Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 3 Constipation Severity Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    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
    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
    Month 1 Abdominal Bloating Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 1 Bowel Movement Frequency Rates Change From Baseline
    Month 2 Bowel Movement Frequency Rates Change From Baseline
    Month 3 Bowel Movement Frequency Rates Change From Baseline
    Month 1 Abdominal Pain Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 2 Abdominal Pain Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Month 3 Abdominal Pain Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

    Full Information

    First Posted
    September 21, 2006
    Last Updated
    November 4, 2019
    Sponsor
    Sucampo Pharma Americas, LLC
    Collaborators
    Takeda
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00380250
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sucampo Pharma Americas, LLC
    Collaborators
    Takeda

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome With Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    590 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lubiprostone
    Arm Type
    Experimental
    Arm Description
    8 mcg capsule twice daily (BID)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Matching placebo capsule twice daily (BID)
    Intervention Type
    Drug
    Intervention Name(s)
    Lubiprostone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Overall Responder Rate
    Description
    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 Outcome Measure Information:
    Title
    Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline
    Description
    SBMs are any bowel movement not associated with rescue medication use.
    Time Frame
    Change from baseline for month 1
    Title
    Month 1 Stool Consistency Change From Baseline
    Description
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
    Time Frame
    Change from baseline for month 1
    Title
    Month 1 Bowel Straining Change From Baseline
    Description
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 1
    Title
    Month 1 Constipation Severity Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline at 28 days
    Title
    Month 1 Symptom Relief
    Description
    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
    Title
    Quality of Life Change From Baseline
    Description
    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
    Title
    Month 2 Responder Rate
    Description
    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.
    Time Frame
    month 2 (28 days)
    Title
    Month 3 Responder Rate
    Description
    Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND: Rescue medication use does not increase during the month as compared to baseline; No discontinuation during the month due to lack of efficacy;AND No ratings during the month of Moderately worse or Significantly worse.
    Time Frame
    month 3 (28 days)
    Title
    Month 1 Responder Rate
    Description
    Symptoms >= Moderately relieved for 4 weeks/month or Significantly relieved for >=2 weeks/month AND: Rescue medication use does not increase during the month as compared to baseline; No discontinuation during the month due to lack of efficacy;AND No ratings during the month of Moderately worse or Significantly worse.
    Time Frame
    month 1 (28 days)
    Title
    Month 2 Abdominal Bloating Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Abdominal Bloating Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 3
    Title
    Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline
    Description
    Any bowel movement not associated with rescue medication use
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline
    Description
    Any bowel movement not associated with rescue medication use
    Time Frame
    Change from baseline for month 3
    Title
    Month 2 Stool Consistency Change From Baseline
    Description
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Stool Consistency Change From Baseline
    Description
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
    Time Frame
    Change from baseline for month 3
    Title
    Month 2 Bowel Straining Change From Baseline
    Description
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Bowel Straining Change From Baseline
    Description
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 3
    Title
    Month 2 Constipation Severity Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Constipation Severity Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 3
    Title
    Month 2 Symptom Relief
    Description
    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
    Title
    Month 3 Symptom Relief
    Description
    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
    Title
    Month 1 Abdominal Bloating Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 1
    Title
    Month 1 Bowel Movement Frequency Rates Change From Baseline
    Time Frame
    Change from baseline for month 1
    Title
    Month 2 Bowel Movement Frequency Rates Change From Baseline
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Bowel Movement Frequency Rates Change From Baseline
    Time Frame
    Change from baseline for month 3
    Title
    Month 1 Abdominal Pain Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 1
    Title
    Month 2 Abdominal Pain Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 2
    Title
    Month 3 Abdominal Pain Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    Change from baseline for month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director, MD
    Organizational Affiliation
    Sucampo Pharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19006537
    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.
    Results Reference
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    Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

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