Bunionectomy Trial With GRT6005

Tris Pharma

Status and phase: Completed; Phase 2

Conditions: Post Operative Pain

Treatments: Drug: Morphine; Drug: Placebo; Drug: GRT6005

Study type: Interventional

Funder types: Industry

Identifiers

NCT00872885

425965

KF5503/37 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 258 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 5 patient groups, including a placebo group

A

Experimental group

Description:

Dose 1

Treatment:

Drug: GRT6005

B

Experimental group

Description:

Dose 2

Treatment:

Drug: GRT6005

C

Experimental group

Description:

Dose 3

Treatment:

Drug: GRT6005

D

Active Comparator group

Description:

Morphine

Treatment:

Drug: Morphine

E

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo