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CompletedNCT00399542Updated Dec 17, 2019Results posted

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

A Phase 3 interventional study of Lubiprostone and Placebo in Irritable Bowel Syndrome and Constipation, sponsored by Sucampo Pharma Americas, LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by Sucampo Pharma Americas, LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
581
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome
  • Constipation

Keywords

  • Irritable Bowel Syndrome With Constipation
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 581 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Sucampo Pharma Americas, LLC is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
581 participants (actual)

Interventions

  • DrugLubiprostone
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Month 1 Spontaneous Bowel Movement Rates Change From Baseline

    Any bowel movement not associated with rescue medication use

    Time frame: 28 days

  2. 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

  3. Month 1 Bowel Straining Change From Baseline

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

    Time frame: 28 days

  4. Month 1 Constipation Severity Change From Baseline

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

    Time frame: 28 days

  5. 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

  6. 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

  7. 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

  8. 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

  9. Month 1 Abdominal Pain Change From Baseline

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

    Time frame: 28 days

  10. Month 2 Abdominal Pain Change From Baseline

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

    Time frame: 28 days

  11. Month 3 Abdominal Pain Change From Baseline

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

    Time frame: 28 days

  12. Month 1 Abdominal Bloating Change From Baseline

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

    Time frame: 28 days

  13. Month 2 Abdominal Bloating Change From Baseline

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

    Time frame: 28 days

  14. Month 3 Abdominal Bloating Change From Baseline

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

    Time frame: 28 days

  15. Month 2 Spontaneous Bowel Movement Rates Change From Baseline

    Any bowel movement not associated with rescue medication use

    Time frame: 28 days

  16. Month 3 Spontaneous Bowel Movement Rates Change From Baseline

    Any bowel movement not associated with rescue medication use

    Time frame: 28 days

  17. 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

  18. 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

  19. Month 2 Bowel Straining Change From Baseline

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

    Time frame: 28 days

  20. Month 3 Bowel Straining Change From Baseline

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

    Time frame: 28 days

  21. Month 2 Constipation Severity Change From Baseline

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

    Time frame: 28 days

  22. Month 3 Constipation Severity Change From Baseline

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

    Time frame: 28 days

  23. 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

  24. 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

  25. 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

  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

07

Results

Posted Oct 31, 2008

Participant flow

First subject enrolled 05/19/05; last subject observed 08/02/06, at 65 centers across the US

Participant flow — Overall Study
MilestoneLubiprostonePlacebo
Started387194
Completed303151
Not completed8443
Withdrew: Adverse event1815
Withdrew: Protocol violation133
Withdrew: Withdrawal by subject2810
Withdrew: Lack of efficacy188
Withdrew: Lost to follow-up66
Withdrew: Other10
Withdrew: Physician decision01

Outcome measures

PrimaryOverall 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
Reported as:
Number · percentage of participants
Overall Responder Status
percentage of participantsLubiprostonePlacebo
Overall Responder Status12.15.7
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.023 (No adjustment)Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality
SecondaryMonth 1 Spontaneous Bowel Movement Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Time frame:
28 days
Reported as:
Mean · spontaneous bowel movements (SBMs)/week
Month 1 Spontaneous Bowel Movement Rates Change From Baseline
spontaneous bowel movements (SBMs)/weekLubiprostonePlacebo
Month 1 Spontaneous Bowel Movement Rates Change From Baseline1.55 ± 3.0711.29 ± 2.934
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.391Adjusted for center
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 1 Stool Consistency Change From Baseline
units on a scaleLubiprostonePlacebo
Month 1 Stool Consistency Change From Baseline-0.47 ± 0.673-0.37 ± 0.582
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.151Adjusted for center
SecondaryMonth 1 Bowel Straining Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 1 Bowel Straining Change From Baseline
units on a scaleLubiprostonePlacebo
Month 1 Bowel Straining Change From Baseline-0.54 ± 0.719-0.42 ± 0.628
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.163Adjusted for center
SecondaryMonth 1 Constipation Severity Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 1 Constipation Severity Change From Baseline
units on a scaleLubiprostonePlacebo
Month 1 Constipation Severity Change From Baseline-0.41 ± 0.606-0.33 ± 0.495
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.185Adjusted for center
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 1 Symptom Relief
units on a scaleLubiprostonePlacebo
Month 1 Symptom Relief0.69 ± 1.0580.60 ± 1.043
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.300
SecondaryMonth 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
Reported as:
Number · percentage of participants
Month 1 Responder Rate
percentage of participantsLubiprostonePlacebo
Month 1 Responder Rate9.86.8
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.303 (Sequential closed testing procedures were employed)Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality
SecondaryMonth 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
Reported as:
Number · percentage of participants
Month 2 Responder Rate
percentage of participantsLubiprostonePlacebo
Month 2 Responder Rate16.19.9
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.047 (Sequential closed testing procedures were employed)Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality
SecondaryMonth 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
Reported as:
Number · percentage of participants
Month 3 Responder Rate
percentage of participantsLubiprostonePlacebo
Month 3 Responder Rate13.55.7
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.008 (Sequential closed testing procedures were employed)Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality
SecondaryMonth 1 Abdominal Pain Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 1 Abdominal Pain Change From Baseline
units on a scaleLubiprostonePlacebo
Month 1 Abdominal Pain Change From Baseline-0.32 ± 0.600-0.29 ± 0.450
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.663Adjusted for center
SecondaryMonth 2 Abdominal Pain Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 2 Abdominal Pain Change From Baseline
units on a scaleLubiprostonePlacebo
Month 2 Abdominal Pain Change From Baseline-0.44 ± 0.707-0.33 ± 0.601
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.224Adjusted for center
SecondaryMonth 3 Abdominal Pain Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 3 Abdominal Pain Change From Baseline
units on a scaleLubiprostonePlacebo
Month 3 Abdominal Pain Change From Baseline-0.47 ± 0.746-0.35 ± 0.619
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.271Adjusted for center
SecondaryMonth 1 Abdominal Bloating Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 1 Abdominal Bloating Change From Baseline
units on a scaleLubiprostonePlacebo
Month 1 Abdominal Bloating Change From Baseline-0.31 ± 0.614-0.28 ± 0.430
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.945Adjusted for center
SecondaryMonth 2 Abdominal Bloating Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 2 Abdominal Bloating Change From Baseline
units on a scaleLubiprostonePlacebo
Month 2 Abdominal Bloating Change From Baseline-0.43 ± 0.741-0.33 ± 0.611
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.352
SecondaryMonth 3 Abdominal Bloating Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 3 Abdominal Bloating Change From Baseline
units on a scaleLubiprostonePlacebo
Month 3 Abdominal Bloating Change From Baseline-0.45 ± 0.760-0.35 ± 0.641
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.180Adjusted for center
SecondaryMonth 2 Spontaneous Bowel Movement Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Time frame:
28 days
Reported as:
Mean · SBMs/week
Month 2 Spontaneous Bowel Movement Rates Change From Baseline
SBMs/weekLubiprostonePlacebo
Month 2 Spontaneous Bowel Movement Rates Change From Baseline1.61 ± 3.1911.39 ± 3.495
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.275Adjusted for center
SecondaryMonth 3 Spontaneous Bowel Movement Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Time frame:
28 days
Reported as:
Mean · SBMs/week
Month 3 Spontaneous Bowel Movement Rates Change From Baseline
SBMs/weekLubiprostonePlacebo
Month 3 Spontaneous Bowel Movement Rates Change From Baseline1.43 ± 3.0611.42 ± 3.584
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.722Adjusted for center
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 2 Stool Consistency Change From Baseline
units on a scaleLubiprostonePlacebo
Month 2 Stool Consistency Change From Baseline-0.50 ± 0.700-0.41 ± 0.724
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.177Adjusted for center
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 3 Stool Consistency Change From Baseline
units on a scaleLubiprostonePlacebo
Month 3 Stool Consistency Change From Baseline-0.49 ± 0.686-0.39 ± 0.748
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.082Adjusted for center
SecondaryMonth 2 Bowel Straining Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 2 Bowel Straining Change From Baseline
units on a scaleLubiprostonePlacebo
Month 2 Bowel Straining Change From Baseline-0.62 ± 0.817-0.50 ± 0.745
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.110Adjusted for center
SecondaryMonth 3 Bowel Straining Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 3 Bowel Straining Change From Baseline
units on a scaleLubiprostonePlacebo
Month 3 Bowel Straining Change From Baseline-0.63 ± 0.813-0.50 ± 0.803
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.146Adjusted for center
SecondaryMonth 2 Constipation Severity Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 2 Constipation Severity Change From Baseline
units on a scaleLubiprostonePlacebo
Month 2 Constipation Severity Change From Baseline-0.51 ± 0.732-0.42 ± 0.664
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.373Adjusted for center
SecondaryMonth 3 Constipation Severity Change From Baseline

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

Time frame:
28 days
Reported as:
Mean · units on a scale
Month 3 Constipation Severity Change From Baseline
units on a scaleLubiprostonePlacebo
Month 3 Constipation Severity Change From Baseline-0.53 ± 0.760-0.42 ± 0.679
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.339Adjusted for center
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 2 Symptom Relief
units on a scaleLubiprostonePlacebo
Month 2 Symptom Relief0.79 ± 1.1400.55 ± 1.256
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.023
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 3 Symptom Relief
units on a scaleLubiprostonePlacebo
Month 3 Symptom Relief0.75 ± 1.2490.56 ± 1.222
Statistical analysis
  • Lubiprostone vs Placebo · Cochran-Mantel-Haenszel · p = 0.073
SecondaryMonth 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
Reported as:
Mean · units on a scale
Month 3 Quality of Life Change From Baseline
units on a scaleLubiprostonePlacebo
Month 3 Quality of Life Change From Baseline17.3 ± 17.4613.4 ± 16.26
Statistical analysis
  • Lubiprostone vs Placebo · ANCOVA · p = 0.062Adjusted for center
SecondaryMonth 1 Bowel Movement Rates Change From Baseline
Time frame:
28 days
Reported as:
Mean · bowel movements (BMs)/week
Month 1 Bowel Movement Rates Change From Baseline
bowel movements (BMs)/weekLubiprostonePlacebo
Month 1 Bowel Movement Rates Change From Baseline1.30 ± 2.7870.87 ± 3.104
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.060
SecondaryMonth 2 Bowel Movement Rates Change From Baseline
Time frame:
28 days
Reported as:
Mean · BMs/week
Month 2 Bowel Movement Rates Change From Baseline
BMs/weekLubiprostonePlacebo
Month 2 Bowel Movement Rates Change From Baseline1.29 ± 2.8750.95 ± 3.444
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.290
SecondaryMonth 3 Bowel Movement Rates Change From Baseline
Time frame:
28 days
Reported as:
Mean · BMs/week
Month 3 Bowel Movement Rates Change From Baseline
BMs/weekLubiprostonePlacebo
Month 3 Bowel Movement Rates Change From Baseline1.17 ± 2.7570.97 ± 3.309
Statistical analysis
  • Lubiprostone vs Placebo · van Elteren nonparametric test · p = 0.495

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lubiprostone———
Placebo———
Most frequent serious events
Most frequent serious events
EventLubiprostonePlacebo
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3841/195
Small intestine gangreneGastrointestinal disorders0/3841/195
Small intestinal obstructionGastrointestinal disorders0/3841/195
Abdominal adhesionsGastrointestinal disorders0/3841/195
CholecystitisHepatobiliary disorders1/3840/195
Non-cardiac chest painGeneral disorders1/3840/195
Most frequent other events
Most frequent other events
EventLubiprostonePlacebo
NauseaGastrointestinal disorders34/38411/195
DiarrhoeaGastrointestinal disorders23/38410/195
HeadacheNervous system disorders16/38411/195

Baseline characteristics

Age, Continuous
Age, Continuous(years)LubiprostonePlaceboTotal
Mean45.5 ± 12.9347.3 ± 13.3446.1 ± 13.08
Sex: Female, Male
Sex: Female, Male(Participants)LubiprostonePlaceboTotal
Female343179522
Male361349
Height
Height(inches)LubiprostonePlaceboTotal
Mean64.7 ± 3.1565.0 ± 3.3464.8 ± 3.21
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00399542
Lead sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Nov 15, 2006
Start date
May 2005
Primary completion
Jul 2006
Completion
Jul 2006
Results posted
Oct 31, 2008
Last update
Dec 17, 2019

Study contacts

Medical Monitor, MD
study director · Sucampo Pharmaceuticals, Inc.
View the source record on ClinicalTrials.gov ↗

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