Status:
COMPLETED
A Study to Compare Patient-controlled Pain Medications Delivered Either Through the Skin or Intravenously
Lead Sponsor:
Janssen-Cilag International NV
Collaborating Sponsors:
Alza Corporation, DE, USA
Conditions:
Pain
Analgesia, Patient-Controlled
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in th...
Detailed Description
This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention) study to evaluate the clinical use, safety and ease of care of two patient-...
Eligibility Criteria
Inclusion
- Patients who meet the criteria of American Society of Anesthesiology (ASA) pre-operative physical status I, II, or III
- Patients expected to have moderate or severe pain after a major abdominal or orthopedic procedure
- Patients expected to remain hospitalized for at least 24 hours postoperatively
Exclusion
- Known allergy or hypersensitivity to fentanyl, morphine, or to skin adhesives
- Known or suspected to be dependent on strong opioids or to have abused any drug substance or alcohol
- Severe respiratory symptoms
- Chronic pain disorder
- Pregnant or nursing women, or those lacking adequate contraception
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
657 Patients enrolled
Trial Details
Trial ID
NCT00996177
Start Date
June 1 2004
End Date
April 1 2005
Last Update
January 29 2014
Active Locations (44)
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1
Vienna, Austria
2
Brussels, Belgium
3
Ghent, Belgium
4
Leuven, Belgium