Bunionectomy Trial With GRT6005

Phase 2

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: GRT6005; Drug: Placebo; Drug: Morphine

• Registration Number: NCT00872885
• Lead Sponsor: Tris Pharma, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2009-08
• Study Completion: 2009-10
• Disposition First Submitted: 2010-06-11
• Disposition First Submitted QC: 2010-06-11
• Disposition First Posted: 2010-06-14
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	GRT6005	Dose 3
E	Placebo	Placebo
B	GRT6005	Dose 2
A	GRT6005	Dose 1
D	Morphine	Morphine

Primary Outcome Measures

Name	Time	Method
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments	8 hours

Secondary Outcome Measures

Name	Time	Method
Time to first rescue medication	24 hours
Patient Global Impression of Change	24 hours
Amount of rescue medication	24 hours
Adverse events	24 hours	Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values

Trial Locations

Locations (1)

Premier Research Group Ltd; 🇺🇸 Austin, Texas, United States