Clinical Trial: Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Buni
Brief Summary: The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.
Detailed Summary:
Sponsor: Trevena Inc.
Current Primary Outcome: Proportion of patients who respond to study medication at the 48-hr Numeric Pain Rating Scale (NRS) assessment compared to placebo. [ Time Frame: 48 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with hypoventilation events compared to morphine. [ Time Frame: 48 hours ]
- Duration of hypoventilation events compared to morphine. [ Time Frame: 48 hours ]
- Proportion of patients who respond to study medication at the 48-hr NRS assessment compared to morphine. [ Time Frame: 48 hours ]
- Number of patients with treatment-related adverse events compared to placebo and compared to morphine. [ Time Frame: 48 hours ]
Original Secondary Outcome: Same as current
Information By: Trevena Inc.
Dates:
Date Received: May 12, 2016
Date Started: May 2016
Date Completion:
Last Updated: May 11, 2017
Last Verified: May 2017
