A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients with acute pain following bunionectomy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag International NV
• Collaborator: Grünenthal GmbH
• Treatments: Tapentadol

Criteria

Inclusion Criteria:

• Patients must be undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only, with or without the Akin procedure

• Patients must be healthy or medically stable on the basis of clinical laboratory tests performed at screening

• Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control and have a negative serum pregnancy test at screening and a negative urine pregnancy test before surgery

• If a male, must use an approved method of birth control and does not donate sperm from the day of study drug administration until 3 months afterwards

• Qualifying baseline Pain Intensity must be rated as greater than or equal to 4 on an 11-point (0 to 10) PI NRS, recorded within 30 minutes before randomization, no earlier than 10 hours after the first surgical incision and within 9 hours after termination of the continuous Popliteal Sciatic Block (PSB) infusion Exclusion Criteria: - History of seizure disorder or epilepsy, severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, malignancy in the past 2 years with the exception of successfully treated basal cell carcinoma

• Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening

• Renal insufficiency, impaired hepatic function

• Use of anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, serotonin norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs) or triptans