Hallux Valgus Clinical Trial
Official title:
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy Followed by a Voluntary Open-Label Extension
NCT number | NCT00364247 |
Other study ID # | CR011215 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | August 11, 2006 |
Last updated | June 2, 2011 |
Est. completion date | May 2007 |
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 3 different dose levels of CG5503 compared with oxycodone and with placebo in patients who have had a bunionectomy, and to assess the safety of the drug for 9 days after patients are discharged from the hospital.
Status | Completed |
Enrollment | 602 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients must undergo primary unilateral first metatarsal bunionectomy - pain intensity must be moderate to severe following stoppage of a continuous popliteal sciatic block (a nerve block with local anesthetic that numbs the foot) - female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active. Exclusion Criteria: - Patients will be excluded from the study if they have a history of seizure disorder or epilepsy - history of malignancy within the past 2 years before starting the study - history of alcohol or drug abuse - evidence of active infections that may spread to other areas of the body - clinical laboratory values reflecting moderate or severe renal insufficiency - currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Grünenthal GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary effectiveness outcome for this study is SPID48 (i.e., the sum of pain intensity difference at 48 hours relative to the first dose). | |||
Secondary | Secondary effectiveness outcomes include, among others, the effect of CG5503 IR on the time to the need for the first rescue pain medication during the double-blind treatment period, and the SPID at 12, 24, and 72 hours relative to first dose. |
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