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

NCT00399542 | Completed Phase 3 Results

• 1 other identifier: 0211SIB-0432
• Study Type: interventional
• Target: 581
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome; Constipation

Keywords

Irritable Bowel Syndrome With Constipation

Outcome Measures

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.

  12 weeks

Secondary Outcomes (28)

• Month 1 Spontaneous Bowel Movement Rates Change From Baseline

  28 days

• Month 1 Stool Consistency Change From Baseline

  28 days

• Month 1 Bowel Straining Change From Baseline

  28 days

• Month 1 Constipation Severity Change From Baseline

  28 days

• Month 1 Symptom Relief

  28 days

Interventions

Lubiprostone DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sucampo Pharma Americas, LLC: lead
• Sucampo Pharmaceuticals, Inc.: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome; Constipation

Interventions

Lubiprostone

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Results Point of Contact

• Title: Raymond Panas, PhD
• Organization: Sucampo Pharmaceuticals, Inc.

info@sucampo.com

301-961-3400

Study Officials

• Medical Monitor, MD

  Sucampo Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 15, 2006
• Study Start: May 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: December 17, 2019
• Results First Posted: October 31, 2008

Record last verified: 2013-09