Trial | NCT00380250  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    lubiprostone ...

  • Study Participants

    590
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 Started
May 31
2005
Study Completion
Jul 31
2006
Results Posted
Feb 11
2014
Estimate
Last Update
Nov 15
2019

Drug Lubiprostone

Drug Placebo

Lubiprostone Experimental

8 mcg capsule twice daily (BID)

Placebo Placebo Comparator

Matching placebo capsule twice daily (BID)

Criteria 

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

Summary

Lubiprostone Study Period I

Placebo Study Period I

All Events

Event Type Organ System Event Term Lubiprostone Study Period I Placebo Study Period I

Overall Responder Rate

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

Lubiprostone Study Period I

13.8
percentage of participants

Placebo Study Period I

7.8
percentage of participants

Month 1 Abdominal Bloating Change From Baseline

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

Lubiprostone Study Period I

-0.3
Scale score (Mean)
Standard Deviation: 0.585

Placebo Study Period I

-0.24
Scale score (Mean)
Standard Deviation: 0.516

Month 1 Bowel Movement Frequency Rates Change From Baseline

Lubiprostone Study Period I

1.22
BM/week (Mean)
Standard Deviation: 2.234

Placebo Study Period I

0.88
BM/week (Mean)
Standard Deviation: 2.093

Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline

SBMs are any bowel movement not associated with rescue medication use.

Lubiprostone Study Period I

1.54
SBM/week (Mean)
Standard Deviation: 2.462

Placebo Study Period I

1.21
SBM/week (Mean)
Standard Deviation: 2.286

Month 1 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

Lubiprostone Study Period I

-0.51
Scale score (Mean)
Standard Deviation: 0.690

Placebo Study Period I

-0.33
Scale score (Mean)
Standard Deviation: 0.626

Month 1 Bowel Straining Change From Baseline

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

Lubiprostone Study Period I

-0.53
Scale score (Mean)
Standard Deviation: 0.739

Placebo Study Period I

-0.36
Scale score (Mean)
Standard Deviation: 0.694

Month 1 Constipation Severity Change From Baseline

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

Lubiprostone Study Period I

-0.41
Scale score (Mean)
Standard Deviation: 0.602

Placebo Study Period I

-0.29
Scale score (Mean)
Standard Deviation: 0.568

Month 1 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

Lubiprostone Study Period I

0.66
Scale score (Mean)
Standard Deviation: 1.212

Placebo Study Period I

0.57
Scale score (Mean)
Standard Deviation: 1.088

Quality of Life Change From Baseline

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

Lubiprostone Study Period I

16.7
Scale score (Mean)
Standard Deviation: 17.36

Placebo Study Period I

16.8
Scale score (Mean)
Standard Deviation: 19.72

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 during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.

Lubiprostone Study Period I

15.9
percent of participants

Placebo Study Period I

9.3
percent of participants

Month 3 Responder Rate

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.

Lubiprostone Study Period I

15.9
percent of participants

Placebo Study Period I

10.4
percent of participants

Month 1 Responder Rate

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.

Lubiprostone Study Period I

10.0
percent of participants

Placebo Study Period I

6.2
percent of participants

Month 2 Abdominal Bloating Change From Baseline

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

Lubiprostone Study Period I

-0.42
Scale score (Mean)
Standard Deviation: 0.693

Placebo Study Period I

-0.35
Scale score (Mean)
Standard Deviation: 0.621

Month 3 Abdominal Bloating Change From Baseline

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

Lubiprostone Study Period I

-0.43
Scale score (Mean)
Standard Deviation: 0.734

Placebo Study Period I

-0.37
Scale score (Mean)
Standard Deviation: 0.693

Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Lubiprostone Study Period I

1.59
SBM/week (Mean)
Standard Deviation: 2.795

Placebo Study Period I

1.41
SBM/week (Mean)
Standard Deviation: 2.587

Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline

Any bowel movement not associated with rescue medication use

Lubiprostone Study Period I

1.51
SBM/week (Mean)
Standard Deviation: 2.990

Placebo Study Period I

1.39
SBM/week (Mean)
Standard Deviation: 2.851

Month 2 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

Lubiprostone Study Period I

-0.53
Scale score (Mean)
Standard Deviation: 0.756

Placebo Study Period I

-0.38
Scale score (Mean)
Standard Deviation: 0.658

Month 3 Stool Consistency Change From Baseline

0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)

Lubiprostone Study Period I

-0.52
Scale score (Mean)
Standard Deviation: 0.725

Placebo Study Period I

-0.41
Scale score (Mean)
Standard Deviation: 0.696

Month 2 Bowel Straining Change From Baseline

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

Lubiprostone Study Period I

-0.58
Scale score (Mean)
Standard Deviation: 0.846

Placebo Study Period I

-0.43
Scale score (Mean)
Standard Deviation: 0.762

Month 3 Bowel Straining Change From Baseline

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

Lubiprostone Study Period I

-0.56
Scale score (Mean)
Standard Deviation: 0.847

Placebo Study Period I

-0.45
Scale score (Mean)
Standard Deviation: 0.760

Month 2 Constipation Severity Change From Baseline

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

Lubiprostone Study Period I

-0.5
Scale score (Mean)
Standard Deviation: 0.719

Placebo Study Period I

-0.4
Scale score (Mean)
Standard Deviation: 0.670

Month 3 Constipation Severity Change From Baseline

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

Lubiprostone Study Period I

-0.51
Scale score (Mean)
Standard Deviation: 0.755

Placebo Study Period I

-0.41
Scale score (Mean)
Standard Deviation: 0.712

Month 2 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

Lubiprostone Study Period I

0.76
Scale score (Mean)
Standard Deviation: 1.278

Placebo Study Period I

0.59
Scale score (Mean)
Standard Deviation: 1.203

Month 2 Bowel Movement Frequency Rates Change From Baseline

Lubiprostone Study Period I

1.23
BM/week (Mean)
Standard Deviation: 2.440

Placebo Study Period I

1.1
BM/week (Mean)
Standard Deviation: 2.581

Month 3 Bowel Movement Frequency Rates Change From Baseline

Lubiprostone Study Period I

1.15
BM/week (Mean)
Standard Deviation: 2.744

Placebo Study Period I

1.04
BM/week (Mean)
Standard Deviation: 2.731

Month 1 Abdominal Pain Change From Baseline

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

Lubiprostone Study Period I

-0.29
Scale Score (Mean)
Standard Deviation: 0.588

Placebo Study Period I

-0.27
Scale Score (Mean)
Standard Deviation: 0.508

Month 2 Abdominal Pain Change From Baseline

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

Lubiprostone Study Period I

-0.43
Scale Score (Mean)
Standard Deviation: 0.695

Placebo Study Period I

-0.37
Scale Score (Mean)
Standard Deviation: 0.614

Month 3 Symptom Relief

Significantly worse = -3; Moderately worse = -2; A little bit worse = -1; Unchanged = 0; A little bit relieved=1; Moderately relieved=2; Significantly relieved = 3

Lubiprostone Study Period I

0.74
Scale score (Mean)
Standard Deviation: 1.259

Placebo Study Period I

0.57
Scale score (Mean)
Standard Deviation: 1.277

Month 3 Abdominal Pain Change From Baseline

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

Lubiprostone Study Period I

-0.42
Scale Score (Mean)
Standard Deviation: 0.722

Placebo Study Period I

-0.36
Scale Score (Mean)
Standard Deviation: 0.684

Total

583
Participants

Age, Continuous

47.2
years (Mean)
Full Range: 19.0 to 85.0

Height

64.9
Inches (Mean)
Standard Deviation: 2.96

Race (NIH/OMB)

Sex: Female, Male

Overall Study

Lubiprostone Study Period I

Placebo Study Period I

Drop/Withdrawal Reasons

Lubiprostone Study Period I

Placebo Study Period I