NCT01400139

Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.

An Open-label, Multicenter Study to Assess the Long -Term Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 922 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to characterize the long-term safety of Hydrocodone Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and nonneuropathic pain.

Conditions

• Chronic Nonmalignant and Nonneuropathic Pain

Interventions

Type	Name	Description
DRUG	Hydrocodone bitartrate q24h film-coated tablets	Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2011-07-22
• Last updated: 2020-03-10
• Results posted: 2014-12-04

Locations

98 sites across 1 country: United States