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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Christina Marciniak, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT00662363
First received: April 16, 2008
Last updated: February 27, 2013
Last verified: February 2013
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Constipation
Interventions: Drug: Lubiprostone
Drug: Senna

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the inpatient population of an academic freestanding rehabilitation hospital following admission for impairments related to an orthopedic surgery.The study was approved by the local institutional review board and all subjects provided written informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
72 patients were recruited. There were eight who did not meet inclusion and/or exclusion criteria following consent and screening visit. Reasons for exclusion were: history of Crohn’s disease (1 person), history of irritable bowel disease (1 person), diarrhea on baseline visit day (1 person), or no associated bowel symptom (5 persons).

Reporting Groups
  Description
Lubiprostone Lubiprostone24 µg po BID for 6 days with placebo senna tab
Senna Senna 2 tabs daily for 6 days with placebo lubiprostone tabs

Participant Flow:   Overall Study
    Lubiprostone     Senna  
STARTED     32     32  
COMPLETED     21 [1]   22 [2]
NOT COMPLETED     11     10  
Withdrawal by Subject                 6                 5  
Adverse Event                 0                 3  
Discharged early from rehab                 4                 1  
Protocol Violation                 1                 1  
[1] 1 subject withdrew before taking any study medication
[2] one subject died before receiving any study med 2 subjects withdrew before taking any study med



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lubiprostone Lubiprostone24 µg po BID for 6 days with placebo senna tab
Senna Senna 2 tabs daily for 6 days with placebo lubiprostone tabs
Total Total of all reporting groups

Baseline Measures
    Lubiprostone     Senna     Total  
Number of Participants  
[units: participants]
  32     32     64  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     7     16  
>=65 years     23     25     48  
Age  
[units: years]
Mean ± Standard Deviation
  70.9  ± 11.8     72.2  ± 10.5     71.6  ± 11.5  
Gender  
[units: participants]
     
Female     22     17     39  
Male     10     15     25  
Region of Enrollment  
[units: participants]
     
United States     32     32     64  



  Outcome Measures
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1.  Primary:   Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym)   [ Time Frame: Baseline and Day 7, after treatment completed (6 days of treatment) ]

2.  Primary:   Change in Patient Assessment of Constipation - Quality of Life   [ Time Frame: Baseline and day 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Additional laxatives were frequently required for symptom control


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christina Marciniak
Organization: Rehabilitation Institute of Chicago
phone: 312-238-1000
e-mail: cmarciniak@ric.org


No publications provided


Responsible Party: Christina Marciniak, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT00662363     History of Changes
Other Study ID Numbers: STU00001168
Study First Received: April 16, 2008
Results First Received: October 23, 2012
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration