Bunionectomy Trial With GRT6005
NCT00872885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 258
Last updated 2021-07-15
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).
Conditions
- Post Operative Pain
Interventions
- DRUG
-
GRT6005
liquid formulation, 200 to 600 µg, single dose, one day
- DRUG
-
Morphine
60 mg
- DRUG
-
single dosage
Sponsors & Collaborators
-
Tris Pharma, Inc.
lead INDUSTRY
Principal Investigators
-
John Bothmer, Dr. · Grünenthal GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2009-08-31
- Completion
- 2009-10-31
Countries
- United States
Study Locations
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