Status:
COMPLETED
A Randomized, Double-Blind, Parallel-Arm, Placebo and Active Controlled Dose-Ranging Study of the Efficacy and Safety of Multiple Doses of Tapentadol IR for Postoperative Pain Following Bunionectomy Surgery
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Pain
Postoperative Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study was to evaluate the efficacy and safety of dosing regimens of tapentadol HCl immediate release capsules for the treatment of postoperative pain over a period of 12 hours on the first day fo...
Detailed Description
Tapentadol hydrochloride is a centrally active analgesic (antinociceptive) compound. This was a multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled dose study in men ...
Eligibility Criteria
Inclusion
- Moderate to severe pain intensity within 9 hours of the discontinuation of the popliteal block, and permitted supplemental systemic analgesics, if taken, during the postoperative surgical period
- Moderate to severe categorical pain intensity and a pain intensity VAS = 40 mm
Exclusion
- Randomization less than 10 hours after initiation of the standardized first metatarsal bunionectomy
- History of seizure (including febrile seizure), or loss of consciousness due to head trauma
- Use of antiparkinsonian drugs, neuroleptics, anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), SSRIs, and SNRIs at any time within 30 days of surgery and throughout the study period
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00806247
Start Date
January 1 2005
End Date
August 1 2005
Last Update
May 18 2011
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