Status:
COMPLETED
Intravenous Tapentadol in Post-Bunionectomy Pain
Lead Sponsor:
Grünenthal GmbH
Conditions:
Bunion
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
Eligibility Criteria
Inclusion
- Scheduled to undergo primary unilateral first metatarsal bunionectomy
- Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
- Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).
Exclusion
- History of malignancy within the past 2 years
- Current or history of alcohol or drug abuse.
- Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
- History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
- Severely impaired renal function
- Moderately or severely impaired hepatic function
- Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
- Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01435577
Start Date
September 1 2011
End Date
February 1 2012
Last Update
October 28 2019
Active Locations (1)
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1
Jean Brown Research
Salt Lake City, Utah, United States, 84124