Status:
COMPLETED
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
Lead Sponsor:
Janssen-Cilag International NV
Collaborating Sponsors:
Grünenthal GmbH
Conditions:
Hallux Valgus
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief 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...
Detailed Description
Patients undergoing bunionectomy (a surgical procedure to remove a bunion, an enlargement of the joint at the base of the big toe comprised of bone and soft tissue) often experience moderate to severe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01813890
Start Date
January 1 2013
End Date
January 1 2014
Last Update
January 9 2015
Active Locations (3)
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1
Kaohsiung City, Taiwan
2
Taipei, Taiwan
3
Taoyuan District, Taiwan