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

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.
 
ClinicalTrials.gov Identifier: NCT00380250
Recruitment Status : Completed
First Posted : September 25, 2006
Results First Posted : February 11, 2014
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Mallinckrodt ( Sucampo Pharma Americas, LLC )

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation Drug: Lubiprostone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 590 participants
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
Study Start Date : May 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Lubiprostone
8 mcg capsule twice daily (BID)
Drug: Lubiprostone
Placebo Comparator: Placebo
Matching placebo capsule twice daily (BID)
Drug: Placebo



Primary Outcome Measures :
  1. Overall Responder Rate [ Time Frame: 12 weeks ]

    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 :
  1. Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline [ Time Frame: Change from baseline for month 1 ]
    SBMs are any bowel movement not associated with rescue medication use.

  2. Month 1 Stool Consistency Change From Baseline [ Time Frame: Change from baseline for month 1 ]
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

  3. Month 1 Bowel Straining Change From Baseline [ Time Frame: Change from baseline for month 1 ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

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

  5. Month 1 Symptom Relief [ Time Frame: Change from baseline for month 1 ]
    Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

  6. Quality of Life Change From Baseline [ Time Frame: Change from baseline at 12 weeks ]
    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

  7. Month 2 Responder Rate [ Time Frame: month 2 (28 days) ]

    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.


  8. Month 3 Responder Rate [ Time Frame: month 3 (28 days) ]

    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.

  9. Month 1 Responder Rate [ Time Frame: month 1 (28 days) ]

    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.

  10. Month 2 Abdominal Bloating Change From Baseline [ Time Frame: Change from baseline for month 2 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  11. Month 3 Abdominal Bloating Change From Baseline [ Time Frame: Change from baseline for month 3 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  12. Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline [ Time Frame: Change from baseline for month 2 ]
    Any bowel movement not associated with rescue medication use

  13. Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline [ Time Frame: Change from baseline for month 3 ]
    Any bowel movement not associated with rescue medication use

  14. Month 2 Stool Consistency Change From Baseline [ Time Frame: Change from baseline for month 2 ]
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

  15. Month 3 Stool Consistency Change From Baseline [ Time Frame: Change from baseline for month 3 ]
    0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

  16. Month 2 Bowel Straining Change From Baseline [ Time Frame: Change from baseline for month 2 ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  17. Month 3 Bowel Straining Change From Baseline [ Time Frame: Change from baseline for month 3 ]
    0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  18. Month 2 Constipation Severity Change From Baseline [ Time Frame: Change from baseline for month 2 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  19. Month 3 Constipation Severity Change From Baseline [ Time Frame: Change from baseline for month 3 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  20. Month 2 Symptom Relief [ Time Frame: Change from baseline for month 2 ]
    Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

  21. Month 3 Symptom Relief [ Time Frame: Change from baseline for month 3 ]
    Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

  22. Month 1 Abdominal Bloating Change From Baseline [ Time Frame: Change from baseline for month 1 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  23. Month 1 Bowel Movement Frequency Rates Change From Baseline [ Time Frame: Change from baseline for month 1 ]
  24. Month 2 Bowel Movement Frequency Rates Change From Baseline [ Time Frame: Change from baseline for month 2 ]
  25. Month 3 Bowel Movement Frequency Rates Change From Baseline [ Time Frame: Change from baseline for month 3 ]
  26. Month 1 Abdominal Pain Change From Baseline [ Time Frame: Change from baseline for month 1 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  27. Month 2 Abdominal Pain Change From Baseline [ Time Frame: Change from baseline for month 2 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe

  28. Month 3 Abdominal Pain Change From Baseline [ Time Frame: Change from baseline for month 3 ]
    0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00380250


Sponsors and Collaborators
Sucampo Pharma Americas, LLC
Takeda
Investigators
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Study Director: Medical Director, MD Sucampo Pharmaceuticals, Inc.
Publications of Results:
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Responsible Party: Sucampo Pharma Americas, LLC
ClinicalTrials.gov Identifier: NCT00380250    
Other Study ID Numbers: 0211SIB-0431
First Posted: September 25, 2006    Key Record Dates
Results First Posted: February 11, 2014
Last Update Posted: November 15, 2019
Last Verified: January 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action