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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceutical Company Limited
Information provided by:
Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00399542
First received: November 13, 2006
Last updated: June 2, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Constipation
 Drug: Lubiprostone
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sucampo Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall Responder Status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Any bowel movement not associated with rescue medication use

  • Month 1 Stool Consistency Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

  • Month 1 Bowel Straining Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 1 Constipation Severity Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 1 Symptom Relief [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Abdominal Pain Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Abdominal Pain Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 1 Abdominal Bloating Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Abdominal Bloating Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Abdominal Bloating Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Spontaneous Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Any bowel movement not associated with rescue medication use

  • Month 3 Spontaneous Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Any bowel movement not associated with rescue medication use

  • Month 2 Stool Consistency Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

  • Month 3 Stool Consistency Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

  • Month 2 Bowel Straining Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Bowel Straining Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Constipation Severity Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Constipation Severity Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Symptom Relief [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Month 2 Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Month 3 Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 581
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399542

Sponsors and Collaborators
Sucampo Pharmaceuticals, Inc.
Takeda Pharmaceutical Company Limited
Investigators
Study Director: Medical Monitor, MD Sucampo Pharmaceuticals, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399542     History of Changes
Other Study ID Numbers: 0211SIB-0432
Study First Received: November 13, 2006
Results First Received: October 7, 2008
Last Updated: June 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Sucampo Pharmaceuticals, Inc.:
Irritable Bowel Syndrome With Constipation

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013