Bunionectomy Trial With GRT6005

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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