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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00399542
First Posted: November 15, 2006
Last Update Posted: October 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


Further study details as provided by Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. ):

Primary Outcome Measures:
  • Overall Responder Status [ Time Frame: 12 weeks ]

    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 ]
    Any bowel movement not associated with rescue medication use

  • Month 1 Stool Consistency Change From Baseline [ Time Frame: 28 days ]
    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 ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 1 Constipation Severity Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 1 Symptom Relief [ Time Frame: 28 days ]
    • 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 ]

    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 ]

    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 ]

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

  • Month 2 Abdominal Pain Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Abdominal Pain Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 1 Abdominal Bloating Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Abdominal Bloating Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Abdominal Bloating Change From Baseline [ Time Frame: 28 days ]
    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 ]
    Any bowel movement not associated with rescue medication use

  • Month 3 Spontaneous Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ]
    Any bowel movement not associated with rescue medication use

  • Month 2 Stool Consistency Change From Baseline [ Time Frame: 28 days ]
    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 ]
    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 ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Bowel Straining Change From Baseline [ Time Frame: 28 days ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Constipation Severity Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 3 Constipation Severity Change From Baseline [ Time Frame: 28 days ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  • Month 2 Symptom Relief [ Time Frame: 28 days ]
    • 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 ]
    • 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 ]
    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 ]
  • Month 2 Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ]
  • Month 3 Bowel Movement Rates Change From Baseline [ Time Frame: 28 days ]

Enrollment: 581
Study Start Date: May 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399542


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

Responsible Party: Sucampo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00399542     History of Changes
Other Study ID Numbers: 0211SIB-0432
First Submitted: November 13, 2006
First Posted: November 15, 2006
Results First Submitted: October 7, 2008
Results First Posted: October 31, 2008
Last Update Posted: October 29, 2013
Last Verified: September 2013

Keywords provided by Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. ):
Irritable Bowel Syndrome With Constipation

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action