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

Irritable Bowel Syndrome With Constipation Clinical Trial

Official title:

Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380250
• Other study ID #: 0211SIB-0431
• Status: Completed
• Phase: Phase 3
• Start date: May 2005
• Est. completion date: July 2006

Study information

• Verified date: January 2014
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Intervention

Drug:
• Lubiprostone

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Takeda

References & Publications (1)

Drossman DA, Chey WD, Johanson JF, Fass R, Scott C, Panas R, Ueno R. Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies. Aliment Pharmacol Ther. 2009 Feb 1; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline	SBMs are any bowel movement not associated with rescue medication use.	Change from baseline for month 1
Secondary	Month 1 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	Change from baseline for month 1
Secondary	Month 1 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 1
Secondary	Month 1 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline at 28 days
Secondary	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	Change from baseline for month 1
Secondary	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	Change from baseline at 12 weeks
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 during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.	month 2 (28 days)
Secondary	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.	month 3 (28 days)
Secondary	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.	month 1 (28 days)
Secondary	Month 2 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 2
Secondary	Month 3 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 3
Secondary	Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline	Any bowel movement not associated with rescue medication use	Change from baseline for month 2
Secondary	Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline	Any bowel movement not associated with rescue medication use	Change from baseline for month 3
Secondary	Month 2 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	Change from baseline for month 2
Secondary	Month 3 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	Change from baseline for month 3
Secondary	Month 2 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 2
Secondary	Month 3 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 3
Secondary	Month 2 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 2
Secondary	Month 3 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 3
Secondary	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	Change from baseline for month 2
Secondary	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	Change from baseline for month 3
Secondary	Month 1 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 1
Secondary	Month 1 Bowel Movement Frequency Rates Change From Baseline		Change from baseline for month 1
Secondary	Month 2 Bowel Movement Frequency Rates Change From Baseline		Change from baseline for month 2
Secondary	Month 3 Bowel Movement Frequency Rates Change From Baseline		Change from baseline for month 3
Secondary	Month 1 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 1
Secondary	Month 2 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 2
Secondary	Month 3 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	Change from baseline for month 3