Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-24 @ 4:56 PM
Ignite Modification Date: 2025-12-24 @ 4:56 PM
NCT ID: NCT02401750
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride plus Naltrexone Hydrochloride (b) in patients who have undergone primary, unilateral, distal first metatarsal bunionectomy with osteotomy and internal fixation.
Detailed Description: The study is designed to evaluate the safety and efficacy of oxycodone/naltrexone (a) and oxycodone/naltrexone (b) versus placebo. During the blinded phase of the study (inpatient portion) the dosing regimen is 1 capsule containing Oxycodone Hydrochloride plus Naltrexone Hydrochloride (a) or Oxycodone plus Naltrexone Hydrochloride (b) or placebo taken with 4 to 6 ounces (oz) of water every 6 hours (q6h) for 48 hours following the first dose (Multiple-dose Period) while in-house. Then for the open-label phase of the study (outpatient portion) dosing will occur every 4 to 6 hours prn with Oxycodone plus naltrexone. The active and placebo study medications will appear identical. Study subjects with acute postoperative pain of moderate to severe intensity following unilateral bunionectomy surgery will be randomized after surgery, and will stay at the study center for the duration of the 48-hour double-blind period after dose 1 of study medication. The study will be conducted in the following 4 periods: 1) a pre-treatment period, 2) a multiple-dose inpatient period (double-blind), 3) a multiple-dose outpatient period (open-label), and 4) End of Study/Follow-up.
Study: NCT02401750
Study Brief:
Protocol Section: NCT02401750