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OpenTrials
Completed

NCT Number: NCT00380250

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 With Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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 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

Treatment and study plan

Lubiprostone

Drug

Placebo

Drug

Primary outcomes

  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 outcomes

  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:

    • Rescue medication use does not increase during the month as compared to baseline;
    • No discontinuation during the month due to lack of efficacy;AND
    • 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:

    • Rescue medication use does not increase during the month as compared to baseline;
    • No discontinuation during the month due to lack of efficacy;AND
    • 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

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Takeda

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
Study completion
2006
First posted
Sep 25, 2006
Registry last updated
Nov 15, 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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