Bunionectomy Trial With GRT6005

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00872885

Enrollment

258

Registered

2009-03-31

Start date

2009-03-31

Completion date

2009-10-31

Last updated

2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

analgesic, bunionectomy, surgery, post operative pain, single Hallux valgus repair

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).

Interventions

DRUGGRT6005

liquid formulation, 200 to 600 µg, single dose, one day

DRUGMorphine

60 mg

DRUGPlacebo

single dosage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments	8 hours

Secondary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026