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A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain

Osteoarthrosis Clinical Trial

Official title:
A Multiple-Dose, Safety, Tolerability, and Pharmacokinetic Dose-Escalation Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Patients With Chronic, Moderate to Severe Osteoarthritis Pain

Clinical Trial Summary

Assess the safety, tolerability and pharmacokinetics of multiple doses of 10, 20, 30, and 40 mg of Hydrocodone Bitartrate Extended Release (HC-ER)capsules taken with food at steady state, in subjects with chronic, moderate to severe osteoarthritis (OA) pain.

Clinical Trial Description

Safety parameters assessed included adverse events, physical examinations, vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory testing and overall Arthritis Pain Intensity and opioid side effects ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02222740
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 2
Start date September 2002
Completion date December 2002
View Details
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