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A Study of TRV130 for the Treatment of Pain After Bunionectomy

T

Trevena

Status and phase

Completed
Phase 2

Conditions

Acute Pain

Treatments

Drug: Placebo
Drug: TRV130
Drug: Morphine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02100748
CP130-2001

Details and patient eligibility

About

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

Full description

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Enrollment

333 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
  • Experiences a pain intensity rating of ≥ 4 on an 11 point NRS
  • Able to provide written informed consent before any study procedure.

Exclusion criteria

  • ASA Physical Status Classification System classification of P3 or worse
  • Has surgical or post-surgical complications.
  • Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
  • Has previously participated in another TRV130 clinical study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

333 participants in 6 patient groups, including a placebo group

TRV130 1 mg
Experimental group
Description:
TRV130 1 mg IV Q4H x 48 h
Treatment:
Drug: TRV130
TRV130 2 mg
Experimental group
Description:
TRV130 2 mg IV Q4H x 48 h
Treatment:
Drug: TRV130
TRV130 3 mg
Experimental group
Description:
TRV130 3 mg IV Q4H x 48 h
Treatment:
Drug: TRV130
TRV130 4 mg
Experimental group
Description:
TRV130 4 mg IV Q4H x 48 h
Treatment:
Drug: TRV130
Morphine
Active Comparator group
Description:
Morphine 4 mg IV Q4H x 48 h
Treatment:
Drug: Morphine
Placebo
Placebo Comparator group
Description:
Placebo (D5W) IV Q4H x 48 h
Treatment:
Drug: Placebo

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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