Bunionectomy Trial With GRT6005

Tris Pharma, Inc.258 enrolled

Overview

The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

258

Conditions

Post Operative Pain

Interventions

GRT6005DRUG

liquid formulation, 200 to 600 µg, single dose, one day

MorphineDRUG

60 mg

PlaceboDRUG

single dosage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects scheduled to undergo primary unilateral first metatarsal bunionectomy Exclusion Criteria: * Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients. * Concomitant inflammatory disease. * Life-long history of seizure disorder or epilepsy. * Subjects with impaired renal function * Subjects with impaired hepatic function * Female subjects who are pregnant or breastfeeding. * Resting pulse rate is \<50bpm or \>100 bpm after 5 minutes rest in supine position * resting blood pressure after 5 minutes rest in supine position: Systolic blood pressure is \<100mmHg or \>140 mmHg Diastolic blood pressure is \<60 mmHg or \> 90 mmHg

Locations (1)

Premier Research Group Ltd

Austin, Texas, United States

Outcomes

Primary Outcomes

Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments

Time frame: 8 hours

Secondary Outcomes

Amount of rescue medication

Time frame: 24 hours

Adverse events

Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values

Time frame: 24 hours

Time to first rescue medication

Time frame: 24 hours

Patient Global Impression of Change

Time frame: 24 hours

Data from ClinicalTrials.gov

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