Intravenous Tapentadol in Post-Bunionectomy Pain
Information source: Grünenthal GmbH
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bunion; Pain
Intervention: Tapentadol (Drug); Matching Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Grünenthal GmbH Overall contact:
René Allard, Phone: +49 241-569-3223, Email: Clinical-Trials@grunenthal.com
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.
Clinical Details
Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group, Multicenter Trial to Evaluate the Efficacy and Safety of Multiple Dose Administration of an Intravenous Formulation of Tapentadol in the Treatment of Acute Pain Following Bunionectomy.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Sum of Pain Intensity Differences (SPID 24)
Secondary outcome: Patients Global Impression of ChangeSum of Pain Intensity Difference
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
René Allard, Phone: +49 241-569-3223, Email: Clinical-Trials@grunenthal.com
Jean Brown Research, Salt Lake City, Utah 84124, United States; Recruiting
Shana Shelburne, RN, BSN, Phone: 801-261-1264, Email: SSHELBURNE@JEANBROWNRESEARCH.COM
Georgia Simmons, RN, BSN, CCRP, Phone: 801-694-7846, Email: GSIMMONS@JEANBROWNRESEARCH.COM
Additional Information
Starting date: September 2011
Last updated: October 28, 2011
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