Bunionectomy Trial With GRT6005

July 13, 2021 updated by: Tris Pharma, Inc.

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78705
        • Premier Research Group Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Dose 1
Drug: GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
Other Names:
  • Morphine
EXPERIMENTAL: B
Dose 2
Drug: GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
Other Names:
  • Morphine
EXPERIMENTAL: C
Dose 3
Drug: GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
Other Names:
  • Morphine
ACTIVE_COMPARATOR: D
Morphine
Drug: Morphine
60 mg
PLACEBO_COMPARATOR: E
Placebo
Drug: Placebo
single dosage

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tris Pharma, Inc.

Investigators

  • Study Director: John Bothmer, Dr., Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (ESTIMATE)

March 31, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 425965
  • KF5503/37 (OTHER: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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