search
Back to results

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

Primary Purpose

Irritable Bowel Syndrome, Constipation

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

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Month 1 Spontaneous Bowel Movement Rates Change From Baseline
    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
    3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
    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.
    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.
    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.
    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
    Month 1 Abdominal Bloating Change From Baseline
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    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 Rates Change From Baseline
    Any bowel movement not associated with rescue medication use
    Month 3 Spontaneous Bowel Movement 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
    3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
    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
    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
    Month 1 Bowel Movement Rates Change From Baseline
    Month 2 Bowel Movement Rates Change From Baseline
    Month 3 Bowel Movement Rates Change From Baseline

    Full Information

    First Posted
    November 13, 2006
    Last Updated
    December 13, 2019
    Sponsor
    Sucampo Pharma Americas, LLC
    Collaborators
    Sucampo Pharmaceuticals, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00399542
    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
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sucampo Pharma Americas, LLC
    Collaborators
    Sucampo Pharmaceuticals, Inc.

    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, Constipation
    Keywords
    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
    581 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Lubiprostone
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Overall Responder Status
    Description
    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.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Month 1 Spontaneous Bowel Movement Rates Change From Baseline
    Description
    Any bowel movement not associated with rescue medication use
    Time Frame
    28 days
    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
    28 days
    Title
    Month 1 Bowel Straining Change From Baseline
    Description
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 1 Constipation Severity Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 1 Symptom Relief
    Description
    3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
    Time Frame
    28 days
    Title
    Month 1 Responder Rate
    Description
    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.
    Time Frame
    28 days
    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; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.
    Time Frame
    28 days
    Title
    Month 3 Responder Rate
    Description
    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.
    Time Frame
    28 days
    Title
    Month 1 Abdominal Pain Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 2 Abdominal Pain Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 3 Abdominal Pain Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 1 Abdominal Bloating Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    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
    28 days
    Title
    Month 3 Abdominal Bloating Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 2 Spontaneous Bowel Movement Rates Change From Baseline
    Description
    Any bowel movement not associated with rescue medication use
    Time Frame
    28 days
    Title
    Month 3 Spontaneous Bowel Movement Rates Change From Baseline
    Description
    Any bowel movement not associated with rescue medication use
    Time Frame
    28 days
    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
    28 days
    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
    28 days
    Title
    Month 2 Bowel Straining Change From Baseline
    Description
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 3 Bowel Straining Change From Baseline
    Description
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 2 Constipation Severity Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 3 Constipation Severity Change From Baseline
    Description
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
    Time Frame
    28 days
    Title
    Month 2 Symptom Relief
    Description
    3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
    Time Frame
    28 days
    Title
    Month 3 Symptom Relief
    Description
    3 = Significantly worse, -2 = Moderately worse, 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
    Time Frame
    28 days
    Title
    Month 3 Quality of Life Change From Baseline
    Description
    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
    12 weeks
    Title
    Month 1 Bowel Movement Rates Change From Baseline
    Time Frame
    28 days
    Title
    Month 2 Bowel Movement Rates Change From Baseline
    Time Frame
    28 days
    Title
    Month 3 Bowel Movement Rates Change From Baseline
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Sucampo Pharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs