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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
581
Overall Responder Status
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.
Time frame: 12 weeks
Month 1 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Time frame: 28 days
Month 1 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Time frame: 28 days
Month 1 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 1 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 1 Symptom Relief
* 3 = Significantly worse, -2 = Moderately worse, * 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Time frame: 28 days
Month 1 Responder Rate
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.
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Time frame: 28 days
Month 2 Responder Rate
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.
Time frame: 28 days
Month 3 Responder Rate
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.
Time frame: 28 days
Month 1 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 2 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 3 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 1 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 2 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 3 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 2 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Time frame: 28 days
Month 3 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Time frame: 28 days
Month 2 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Time frame: 28 days
Month 3 Stool Consistency Change From Baseline
0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)
Time frame: 28 days
Month 2 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 3 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 2 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 3 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Month 2 Symptom Relief
* 3 = Significantly worse, -2 = Moderately worse, * 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Time frame: 28 days
Month 3 Symptom Relief
* 3 = Significantly worse, -2 = Moderately worse, * 1 = A little bit worse, 0 = Unchanged, 1 = A little bit relieved, 2 = Moderately relieved, 3 = Significantly relieved
Time frame: 28 days
Month 3 Quality of Life Change From Baseline
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
Time frame: 12 weeks
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