A Study of TRV130 for the Treatment of Pain After Bunionectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

333 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TRV130 1 mg

TRV130 1 mg IV Q4H x 48 h

Group Type EXPERIMENTAL

TRV130

Intervention Type DRUG

TRV130 1 - 4 mg will be administered every 4 hours

TRV130 2 mg

TRV130 2 mg IV Q4H x 48 h

Group Type EXPERIMENTAL

TRV130

Intervention Type DRUG

TRV130 1 - 4 mg will be administered every 4 hours

TRV130 3 mg

TRV130 3 mg IV Q4H x 48 h

Group Type EXPERIMENTAL

TRV130

Intervention Type DRUG

TRV130 1 - 4 mg will be administered every 4 hours

TRV130 4 mg

TRV130 4 mg IV Q4H x 48 h

Group Type EXPERIMENTAL

TRV130

Intervention Type DRUG

TRV130 1 - 4 mg will be administered every 4 hours

Morphine

Morphine 4 mg IV Q4H x 48 h

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine 4 mg will be administered every 4 hours

Placebo

Placebo (D5W) IV Q4H x 48 h

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered every 4 hours

Interventions

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TRV130

TRV130 1 - 4 mg will be administered every 4 hours

Intervention Type DRUG

Morphine

Morphine 4 mg will be administered every 4 hours

Intervention Type DRUG

Placebo

Placebo will be administered every 4 hours

Intervention Type DRUG

Other Intervention Names

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Morphine sulphate Dextrose 5% in water D5W

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No