Bunionectomy Trial With GRT6005

Sponsor

Tris Pharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00872885

Collaborator

(none)

258

Enrollment

Location

Arms

Duration (Months)

36.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: GRT6005 Drug: Morphine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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.

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Dose 1	Drug: GRT6005 liquid formulation, 200 to 600 µg, single dose, one day Other Names: Morphine
Experimental: B Dose 2	Drug: GRT6005 liquid formulation, 200 to 600 µg, single dose, one day Other Names: Morphine
Experimental: C Dose 3	Drug: GRT6005 liquid formulation, 200 to 600 µg, single dose, one day Other Names: Morphine
Active Comparator: D Morphine	Drug: Morphine 60 mg
Placebo Comparator: E Placebo	Drug: Placebo single dosage

Outcome Measures

Primary Outcome Measures

Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments [8 hours]

Secondary Outcome Measures

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
Time to first rescue medication [24 hours]
Patient Global Impression of Change [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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