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OpenTrials
Completed

NCT Number: NCT00399542

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Constipation Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubiprostone

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Month 1 Spontaneous Bowel Movement Rates Change From Baseline

    Time frame: 28 days

    Any bowel movement not associated with rescue medication use

  2. 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)

  3. Month 1 Bowel Straining Change From Baseline

    Time frame: 28 days

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

  4. Month 1 Constipation Severity Change From Baseline

    Time frame: 28 days

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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. Month 1 Abdominal Pain Change From Baseline

    Time frame: 28 days

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

  10. Month 2 Abdominal Pain Change From Baseline

    Time frame: 28 days

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

  11. Month 3 Abdominal Pain Change From Baseline

    Time frame: 28 days

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

  12. Month 1 Abdominal Bloating Change From Baseline

    Time frame: 28 days

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

  13. Month 2 Abdominal Bloating Change From Baseline

    Time frame: 28 days

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

  14. Month 3 Abdominal Bloating Change From Baseline

    Time frame: 28 days

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

  15. Month 2 Spontaneous Bowel Movement Rates Change From Baseline

    Time frame: 28 days

    Any bowel movement not associated with rescue medication use

  16. Month 3 Spontaneous Bowel Movement Rates Change From Baseline

    Time frame: 28 days

    Any bowel movement not associated with rescue medication use

  17. 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)

  18. 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)

  19. Month 2 Bowel Straining Change From Baseline

    Time frame: 28 days

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

  20. Month 3 Bowel Straining Change From Baseline

    Time frame: 28 days

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

  21. Month 2 Constipation Severity Change From Baseline

    Time frame: 28 days

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

  22. Month 3 Constipation Severity Change From Baseline

    Time frame: 28 days

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

  23. 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

  24. 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

  25. 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

  26. Month 1 Bowel Movement Rates Change From Baseline

    Time frame: 28 days

  27. Month 2 Bowel Movement Rates Change From Baseline

    Time frame: 28 days

  28. Month 3 Bowel Movement Rates Change From Baseline

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Sucampo Pharmaceuticals, Inc.

Registry information

Official study title

Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 15, 2006
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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