Trials / Completed
CompletedNCT02222740
A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Zogenix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 10 mg of Hydrocodone Bitartrate Extended Release (HC-ER) | Schedule II Class |
| DRUG | 20 mg of Hydrocodone Bitartrate Extended Release (HC-ER) | Schedule II Class |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2002-12-01
- Completion
- 2002-12-01
- First posted
- 2014-08-21
- Last updated
- 2022-11-10
Source: ClinicalTrials.gov record NCT02222740. Inclusion in this directory is not an endorsement.