MedTrace Logo

Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation

NCT00662363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2013-03-06

Study results available
· View outcomes & findings →

Summary

Patients requiring opioids for post-operative pain control following elective orthopedic procedures which has resulted in constipation symptoms, and who are in inpatient rehabilitation will be randomized to two different treatment arms: lubiprostone or senna. Baseline scores regarding constipation and a quality of life bowel questionnaire will be compared the day following 6 days of treatment intervention.

Conditions

Interventions

DRUG

Lubiprostone

24 µg po BID given with meals for 6 days

DRUG

Senna

2 tabs daily for 6 days

Sponsors & Collaborators

  • Takeda Pharmaceuticals North America, Inc.

    collaborator INDUSTRY

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Christina M Marciniak, MD · Shirley Ryan AbilityLab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662363 on ClinicalTrials.gov