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Completed

NCT Number: NCT00872885

Bunionectomy Trial With GRT6005

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).

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Premier Research Group Ltd

Austin, Texas, 78705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GRT6005

Drug

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

Other names: Morphine

Morphine

Drug

60 mg

Placebo

Drug

single dosage

Primary outcomes

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

    Time frame: 8 hours

Secondary outcomes

  1. Amount of rescue medication

    Time frame: 24 hours

  2. Adverse events

    Time frame: 24 hours

    Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values

  3. Time to first rescue medication

    Time frame: 24 hours

  4. Patient Global Impression of Change

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Tris Pharma, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 31, 2009
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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