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

Irritable Bowel Syndrome 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: NCT00399542
• Other study ID #: 0211SIB-0432
• Status: Completed
• Phase: Phase 3
• Start date: May 2005
• Est. completion date: July 2006

Study information

• Verified date: September 2013
• 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: 581
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• 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 & 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

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Lubiprostone

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 weeks
Secondary	Month 1 Spontaneous Bowel Movement Rates Change From Baseline	Any bowel movement not associated with rescue medication use	28 days
Secondary	Month 1 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	28 days
Secondary	Month 1 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 1 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
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	28 days
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.	28 days
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.	28 days
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.	28 days
Secondary	Month 1 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 2 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 3 Abdominal Pain Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 1 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 2 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 3 Abdominal Bloating Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 2 Spontaneous Bowel Movement Rates Change From Baseline	Any bowel movement not associated with rescue medication use	28 days
Secondary	Month 3 Spontaneous Bowel Movement Rates Change From Baseline	Any bowel movement not associated with rescue medication use	28 days
Secondary	Month 2 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	28 days
Secondary	Month 3 Stool Consistency Change From Baseline	0 = Very loose (watery), 1 = Loose, 2 = Normal, 3 = Hard, 4 = Very hard (little balls)	28 days
Secondary	Month 2 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 3 Bowel Straining Change From Baseline	0 = Absent,1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 2 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
Secondary	Month 3 Constipation Severity Change From Baseline	0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Very Severe	28 days
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	28 days
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	28 days
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	12 weeks
Secondary	Month 1 Bowel Movement Rates Change From Baseline		28 days
Secondary	Month 2 Bowel Movement Rates Change From Baseline		28 days
Secondary	Month 3 Bowel Movement Rates Change From Baseline		28 days