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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT00399542
First received: November 13, 2006
Last updated: September 25, 2013
Last verified: September 2013

November 13, 2006
September 25, 2013
May 2005
July 2006   (final data collection date for primary outcome measure)
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.

Overall Responder Status
Complete list of historical versions of study NCT00399542 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Monthly Responder Status
  • Abdominal Discomfort/Pain
  • Abdominal Bloating
  • Bowel Movement Frequency Rates
  • Stool Consistency
  • Bowel Straining
  • Constipation Severity
  • Symptom Relief
  • Quality of Life
Not Provided
Not Provided
 
Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation
Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Constipation
  • Drug: Lubiprostone
  • Drug: Placebo
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
581
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00399542
0211SIB-0432
Not Provided
Sucampo Pharma Americas, LLC ( Sucampo Pharmaceuticals, Inc. )
Sucampo Pharmaceuticals, Inc.
Takeda
Study Director: Medical Monitor, MD Sucampo Pharmaceuticals, Inc.
Sucampo Pharma Americas, LLC
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP