Clinical Trial: Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty

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 Abdo

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 pain after abdominoplasty.

Detailed Summary:
Sponsor: Trevena Inc.

Current Primary Outcome: Proportion of patients who respond to study medication at the 24-hr Numeric Pain Rating Scale (NRS) assessment compared to placebo. [ Time Frame: 24 hours ]

Original 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 ]

Current Secondary Outcome:

  • Number of patients with hypoventilation events compared to morphine. [ Time Frame: 24 hours ]
  • Duration of hypoventilation events compared to morphine. [ Time Frame: 24 hours ]
  • Proportion of patients who respond to study medication at the 24-hr NRS assessment compared to morphine. [ Time Frame: 24 hours ]
  • Number of patients with treatment-related adverse events compared to placebo and compared to morphine. [ Time Frame: 24 hours ]


Original 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 ]


Information By: Trevena Inc.

Dates:
Date Received: June 9, 2016
Date Started: May 2016
Date Completion:
Last Updated: May 8, 2017
Last Verified: May 2017