Bunionectomy Trial With GRT6005

Post Operative Pain Clinical Trial

Official title:

A Randomized, Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Moderate to Severe Pain Following Bunionectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872885
• Other study ID #: 425965
• Secondary ID: KF5503/37
• Status: Completed
• Phase: Phase 2
• Start date: March 2009
• Est. completion date: October 2009

Study information

• Verified date: July 2021
• Source: Tris Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
• Morphine
60 mg
• Placebo
single dosage

Locations

Country	Name	City	State
United States	Premier Research Group Ltd	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Tris Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments		8 hours
Secondary	Amount of rescue medication		24 hours
Secondary	Adverse events	Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values	24 hours
Secondary	Time to first rescue medication		24 hours
Secondary	Patient Global Impression of Change		24 hours