Bunionectomy Trial With GRT6005

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: GRT6005
* Drug: Morphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Dose 1 | Drug: GRT6005<br>* liquid formulation, 200 to 600 µg, single dose, one day<br>* Other names: Morphine;|
| Experimental: B<br>Dose 2 | Drug: GRT6005<br>* liquid formulation, 200 to 600 µg, single dose, one day<br>* Other names: Morphine;|
| Experimental: C<br>Dose 3 | Drug: GRT6005<br>* liquid formulation, 200 to 600 µg, single dose, one day<br>* Other names: Morphine;|
| Active Comparator: D<br>Morphine | Drug: Morphine<br>* 60 mg<br>|
| Placebo Comparator: E<br>Placebo | Drug: Placebo<br>* single dosage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of rescue medication |  | 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 | 24 hours | 
| Time to first rescue medication |  | 24 hours | 
| Patient Global Impression of Change |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesic, bunionectomy, surgery, post operative pain, single Hallux valgus repair