NCT00380250

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
590

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

February 11, 2014

Completed
Last Updated

November 15, 2019

Status Verified

January 1, 2014

First QC Date

September 21, 2006

Results QC Date

October 7, 2008

Last Update Submit

November 4, 2019

Conditions

Irritable Bowel Syndrome With Constipation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

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

    Change from baseline for month 1

  • Month 1 Stool Consistency Change From Baseline

    Change from baseline for month 1

  • Month 1 Bowel Straining Change From Baseline

    Change from baseline for month 1

  • Month 1 Constipation Severity Change From Baseline

    Change from baseline at 28 days

  • Month 1 Symptom Relief

    Change from baseline for month 1

  • +23 more secondary outcomes

Study Arms (2)

Lubiprostone

EXPERIMENTAL

8 mcg capsule twice daily (BID)

Drug: Lubiprostone

Placebo

PLACEBO COMPARATOR

Matching placebo capsule twice daily (BID)

Drug: Placebo

Interventions

LubiprostoneDRUG
Lubiprostone
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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;29(3):329-41. doi: 10.1111/j.1365-2036.2008.03881.x. Epub 2008 Nov 4.

    PMID: 19006537RESULT

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

AlprostadilFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Results Point of Contact

Title
Medical Information Call Center
Organization
Mallinckrodt Pharmaceuticals
clinicaltrials@mnk.com
800-556-3314

Study Officials

  • Medical Director, 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

September 21, 2006

First Posted

September 25, 2006

Study Start

May 1, 2005

Study Completion

July 1, 2006

Last Updated

November 15, 2019

Results First Posted

February 11, 2014

Record last verified: 2014-01

Data Sharing

IPD Sharing
Will not share