Constipation, Irritable Bowel Syndrome
Conditions
Keywords
Irritable Bowel Syndrome With Constipation
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.
Interventions
DRUGLubiprostone
DRUGPlacebo
Sponsors
Sucampo Pharmaceuticals, Inc.
Sucampo Pharma Americas, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Responder Status | 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
| Measure | Time frame | Description |
|---|---|---|
| Month 3 Bowel Straining Change From Baseline | 28 days | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 2 Constipation Severity Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 3 Constipation Severity Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 2 Symptom Relief | 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 |
| Month 3 Symptom Relief | 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 |
| Month 1 Spontaneous Bowel Movement Rates Change From Baseline | 28 days | Any bowel movement not associated with rescue medication use |
| Month 1 Stool Consistency Change From Baseline | 28 days | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Month 1 Bowel Straining Change From Baseline | 28 days | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 1 Constipation Severity Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 1 Symptom Relief | 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 |
| Month 1 Responder Rate | 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. |
| Month 2 Responder Rate | 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. |
| Month 3 Responder Rate | 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. |
| Month 2 Bowel Straining Change From Baseline | 28 days | 0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 2 Abdominal Pain Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 3 Abdominal Pain Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 1 Abdominal Bloating Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 2 Abdominal Bloating Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 3 Abdominal Bloating Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
| Month 2 Spontaneous Bowel Movement Rates Change From Baseline | 28 days | Any bowel movement not associated with rescue medication use |
| Month 3 Spontaneous Bowel Movement Rates Change From Baseline | 28 days | Any bowel movement not associated with rescue medication use |
| Month 2 Stool Consistency Change From Baseline | 28 days | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Month 3 Stool Consistency Change From Baseline | 28 days | 0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls) |
| Month 3 Quality of Life Change From Baseline | 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 |
| Month 1 Bowel Movement Rates Change From Baseline | 28 days | — |
| Month 2 Bowel Movement Rates Change From Baseline | 28 days | — |
| Month 3 Bowel Movement Rates Change From Baseline | 28 days | — |
| Month 1 Abdominal Pain Change From Baseline | 28 days | 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe |
Participant flow
Recruitment details
First subject enrolled 05/19/05; last subject observed 08/02/06, at 65 centers across the US
Pre-assignment details
Subjects were enrolled after an up to 4 week screening period to meet inclusion/exclusion criteria and randomized on Day 0
Participants by arm
| Arm | Count |
|---|---|
| Lubiprostone Subjects who received active drug | 379 |
| Placebo Subjects who received placebo | 192 |
| Total | 571 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 18 | 15 |
| Overall Study | Lack of Efficacy | 18 | 8 |
| Overall Study | Lost to Follow-up | 6 | 6 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 13 | 3 |
| Overall Study | Withdrawal by Subject | 28 | 10 |
Baseline characteristics
| Characteristic | Lubiprostone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 45.5 years STANDARD_DEVIATION 12.93 | 47.3 years STANDARD_DEVIATION 13.34 | 46.1 years STANDARD_DEVIATION 13.08 |
| Height | 64.7 inches STANDARD_DEVIATION 3.15 | 65.0 inches STANDARD_DEVIATION 3.34 | 64.8 inches STANDARD_DEVIATION 3.21 |
| Sex: Female, Male Female | 343 Participants | 179 Participants | 522 Participants |
| Sex: Female, Male Male | 36 Participants | 13 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 67 / — | 30 / — |
| serious Total, serious adverse events | 2 / — | 2 / — |
Outcome results
Primary
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
Population: Intention to treat (ITT), without Last Observational Carried Forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubiprostone | Overall Responder Status | 12.1 percentage of participants |
| Placebo | Overall Responder Status | 5.7 percentage of participants |
Comparison: 70.6% improvement in response with lubiprostone at 90% statistical powerp-value: 0.023Cochran-Mantel-Haenszel
Secondary
Month 1 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Abdominal Bloating Change From Baseline | -0.31 units on a scale | Standard Deviation 0.614 |
| Placebo | Month 1 Abdominal Bloating Change From Baseline | -0.28 units on a scale | Standard Deviation 0.43 |
p-value: 0.945van Elteren nonparametric test
Secondary
Month 1 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Abdominal Pain Change From Baseline | -0.32 units on a scale | Standard Deviation 0.6 |
| Placebo | Month 1 Abdominal Pain Change From Baseline | -0.29 units on a scale | Standard Deviation 0.45 |
p-value: 0.663van Elteren nonparametric test
Secondary
Month 1 Bowel Movement Rates Change From Baseline
Time frame: 28 days
Population: ITT, with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Bowel Movement Rates Change From Baseline | 1.30 bowel movements (BMs)/week | Standard Deviation 2.787 |
| Placebo | Month 1 Bowel Movement Rates Change From Baseline | 0.87 bowel movements (BMs)/week | Standard Deviation 3.104 |
p-value: 0.06van Elteren nonparametric test
Secondary
Month 1 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Bowel Straining Change From Baseline | -0.54 units on a scale | Standard Deviation 0.719 |
| Placebo | Month 1 Bowel Straining Change From Baseline | -0.42 units on a scale | Standard Deviation 0.628 |
p-value: 0.163van Elteren nonparametric test
Secondary
Month 1 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Constipation Severity Change From Baseline | -0.41 units on a scale | Standard Deviation 0.606 |
| Placebo | Month 1 Constipation Severity Change From Baseline | -0.33 units on a scale | Standard Deviation 0.495 |
p-value: 0.185van Elteren nonparametric test
Secondary
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.
Time frame: 28 days
Population: ITT without LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubiprostone | Month 1 Responder Rate | 9.8 percentage of participants |
| Placebo | Month 1 Responder Rate | 6.8 percentage of participants |
p-value: 0.303Cochran-Mantel-Haenszel
Secondary
Month 1 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Spontaneous Bowel Movement Rates Change From Baseline | 1.55 spontaneous bowel movements (SBMs)/week | Standard Deviation 3.071 |
| Placebo | Month 1 Spontaneous Bowel Movement Rates Change From Baseline | 1.29 spontaneous bowel movements (SBMs)/week | Standard Deviation 2.934 |
p-value: 0.391van Elteren nonparametric test
Secondary
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
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Stool Consistency Change From Baseline | -0.47 units on a scale | Standard Deviation 0.673 |
| Placebo | Month 1 Stool Consistency Change From Baseline | -0.37 units on a scale | Standard Deviation 0.582 |
p-value: 0.151van Elteren nonparametric test
Secondary
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
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 1 Symptom Relief | 0.69 units on a scale | Standard Deviation 1.058 |
| Placebo | Month 1 Symptom Relief | 0.60 units on a scale | Standard Deviation 1.043 |
p-value: 0.3Cochran-Mantel-Haenszel
Secondary
Month 2 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Abdominal Bloating Change From Baseline | -0.43 units on a scale | Standard Deviation 0.741 |
| Placebo | Month 2 Abdominal Bloating Change From Baseline | -0.33 units on a scale | Standard Deviation 0.611 |
p-value: 0.352van Elteren nonparametric test
Secondary
Month 2 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Abdominal Pain Change From Baseline | -0.44 units on a scale | Standard Deviation 0.707 |
| Placebo | Month 2 Abdominal Pain Change From Baseline | -0.33 units on a scale | Standard Deviation 0.601 |
p-value: 0.224van Elteren nonparametric test
Secondary
Month 2 Bowel Movement Rates Change From Baseline
Time frame: 28 days
Population: ITT, with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Bowel Movement Rates Change From Baseline | 1.29 BMs/week | Standard Deviation 2.875 |
| Placebo | Month 2 Bowel Movement Rates Change From Baseline | 0.95 BMs/week | Standard Deviation 3.444 |
p-value: 0.29van Elteren nonparametric test
Secondary
Month 2 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Bowel Straining Change From Baseline | -0.62 units on a scale | Standard Deviation 0.817 |
| Placebo | Month 2 Bowel Straining Change From Baseline | -0.50 units on a scale | Standard Deviation 0.745 |
p-value: 0.11van Elteren nonparametric test
Secondary
Month 2 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Constipation Severity Change From Baseline | -0.51 units on a scale | Standard Deviation 0.732 |
| Placebo | Month 2 Constipation Severity Change From Baseline | -0.42 units on a scale | Standard Deviation 0.664 |
p-value: 0.373van Elteren nonparametric test
Secondary
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
Population: ITT without LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubiprostone | Month 2 Responder Rate | 16.1 percentage of participants |
| Placebo | Month 2 Responder Rate | 9.9 percentage of participants |
p-value: 0.047Cochran-Mantel-Haenszel
Secondary
Month 2 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Spontaneous Bowel Movement Rates Change From Baseline | 1.61 SBMs/week | Standard Deviation 3.191 |
| Placebo | Month 2 Spontaneous Bowel Movement Rates Change From Baseline | 1.39 SBMs/week | Standard Deviation 3.495 |
p-value: 0.275van Elteren nonparametric test
Secondary
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
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Stool Consistency Change From Baseline | -0.50 units on a scale | Standard Deviation 0.7 |
| Placebo | Month 2 Stool Consistency Change From Baseline | -0.41 units on a scale | Standard Deviation 0.724 |
p-value: 0.177van Elteren nonparametric test
Secondary
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
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 2 Symptom Relief | 0.79 units on a scale | Standard Deviation 1.14 |
| Placebo | Month 2 Symptom Relief | 0.55 units on a scale | Standard Deviation 1.256 |
p-value: 0.023Cochran-Mantel-Haenszel
Secondary
Month 3 Abdominal Bloating Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Abdominal Bloating Change From Baseline | -0.45 units on a scale | Standard Deviation 0.76 |
| Placebo | Month 3 Abdominal Bloating Change From Baseline | -0.35 units on a scale | Standard Deviation 0.641 |
p-value: 0.18van Elteren nonparametric test
Secondary
Month 3 Abdominal Pain Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Abdominal Pain Change From Baseline | -0.47 units on a scale | Standard Deviation 0.746 |
| Placebo | Month 3 Abdominal Pain Change From Baseline | -0.35 units on a scale | Standard Deviation 0.619 |
p-value: 0.271van Elteren nonparametric test
Secondary
Month 3 Bowel Movement Rates Change From Baseline
Time frame: 28 days
Population: ITT, with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Bowel Movement Rates Change From Baseline | 1.17 BMs/week | Standard Deviation 2.757 |
| Placebo | Month 3 Bowel Movement Rates Change From Baseline | 0.97 BMs/week | Standard Deviation 3.309 |
p-value: 0.495van Elteren nonparametric test
Secondary
Month 3 Bowel Straining Change From Baseline
0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Bowel Straining Change From Baseline | -0.63 units on a scale | Standard Deviation 0.813 |
| Placebo | Month 3 Bowel Straining Change From Baseline | -0.50 units on a scale | Standard Deviation 0.803 |
p-value: 0.146van Elteren nonparametric test
Secondary
Month 3 Constipation Severity Change From Baseline
0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Constipation Severity Change From Baseline | -0.53 units on a scale | Standard Deviation 0.76 |
| Placebo | Month 3 Constipation Severity Change From Baseline | -0.42 units on a scale | Standard Deviation 0.679 |
p-value: 0.339van Elteren nonparametric test
Secondary
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
Population: ITT without LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Quality of Life Change From Baseline | 17.3 units on a scale | Standard Deviation 17.46 |
| Placebo | Month 3 Quality of Life Change From Baseline | 13.4 units on a scale | Standard Deviation 16.26 |
p-value: 0.062ANCOVA
Secondary
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
Population: ITT without LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lubiprostone | Month 3 Responder Rate | 13.5 percentage of participants |
| Placebo | Month 3 Responder Rate | 5.7 percentage of participants |
p-value: 0.008Cochran-Mantel-Haenszel
Secondary
Month 3 Spontaneous Bowel Movement Rates Change From Baseline
Any bowel movement not associated with rescue medication use
Time frame: 28 days
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Spontaneous Bowel Movement Rates Change From Baseline | 1.43 SBMs/week | Standard Deviation 3.061 |
| Placebo | Month 3 Spontaneous Bowel Movement Rates Change From Baseline | 1.42 SBMs/week | Standard Deviation 3.584 |
p-value: 0.722van Elteren nonparametric test
Secondary
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
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Stool Consistency Change From Baseline | -0.49 units on a scale | Standard Deviation 0.686 |
| Placebo | Month 3 Stool Consistency Change From Baseline | -0.39 units on a scale | Standard Deviation 0.748 |
p-value: 0.082van Elteren nonparametric test
Secondary
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
Population: ITT with LOCF
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubiprostone | Month 3 Symptom Relief | 0.75 units on a scale | Standard Deviation 1.249 |
| Placebo | Month 3 Symptom Relief | 0.56 units on a scale | Standard Deviation 1.222 |
p-value: 0.073Cochran-Mantel-Haenszel