Back to resultsBunionectomy Trial With GRT6005
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GRT6005
Morphine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring analgesic, bunionectomy, surgery, post operative pain, single Hallux valgus repair
Eligibility Criteria
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
Sites / Locations
- Premier Research Group Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
A
B
C
D
E
Arm Description
Dose 1
Dose 2
Dose 3
Morphine
Placebo
Outcomes
Primary Outcome Measures
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
Secondary Outcome Measures
Amount of rescue medication
Adverse events
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
Patient Global Impression of Change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00872885
Brief Title
Bunionectomy Trial With GRT6005
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tris Pharma, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
analgesic, bunionectomy, surgery, post operative pain, single Hallux valgus repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
B
Arm Type
Experimental
Arm Description
Dose 2
Arm Title
C
Arm Type
Experimental
Arm Description
Dose 3
Arm Title
D
Arm Type
Active Comparator
Arm Description
Morphine
Arm Title
E
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
GRT6005
Other Intervention Name(s)
Morphine
Intervention Description
liquid formulation, 200 to 600 µg, single dose, one day
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
60 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single dosage
Primary Outcome Measure Information:
Title
Sum of pain intensity 2-10 hours after Investigational medicinal product intake. Pain assessments
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Amount of rescue medication
Time Frame
24 hours
Title
Adverse events
Description
Adverse Events reported by the participant as well as electrocardiogram, a measure of electrical activity of the heart and laboratory values
Time Frame
24 hours
Title
Time to first rescue medication
Time Frame
24 hours
Title
Patient Global Impression of Change
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Bothmer, Dr.
Organizational Affiliation
Grünenthal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Premier Research Group Ltd
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
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Bunionectomy Trial With GRT6005
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