Clinical trial NCT01435577: Intravenous Tapentadol in Post-Bunionectomy Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bunion
Pain
Keywords: Bunionectomy
Postsurgical Pain
Acute Pain
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
First posted: 2011-09-16
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Sum of Pain Intensity Differences (SPID 24)
timeFrame: Baseline value; up to 24 hours after first study drug administration
Secondary outcomes:
measure: Mean Pain Intensity Scores at Fixed Time Points
timeFrame: Baseline; up to 48 hours
measure: Pain Intensity Differences at Fixed Time Points
timeFrame: Starting at 15 minutes and up to 48 hours after first drug administration
measure: Patient Global Impression of Change After 12 Hours of Treatment
timeFrame: Baseline value to 12 hours after first study drug administration
measure: Patients Global Impression of Change After 24 Hours of Treatment
timeFrame: Baseline value to 24 hours after study drug administration
measure: Patient Global Impression of Change After 48 Hours of Treatment
timeFrame: Baseline value to 48 hours after first study drug administration
measure: Sum of Pain Intensity Differences After 60 Minutes
timeFrame: Baseline value to 60 minutes after first study drug administration
measure: Sum of Pain Intensity Differences After 4 Hours
timeFrame: Baseline value to 4 hours after first study drug intake
measure: Sum of Pain Intensity Differences After 8 Hours
timeFrame: Baseline value to 8 hours after first study drug administration
measure: Sum of Pain Intensity Differences After 12 Hours
timeFrame: Baseline value to 12 hours after first study drug administration
measure: Sum of Pain Intensity Differences After 48 Hours
timeFrame: Baseline value to 48 hours after first study drug administration
measure: Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores
timeFrame: Baseline value to 12 hours after first study drug administration
measure: Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores
timeFrame: Baseline value to 24 hours after first study drug administration
measure: Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores
timeFrame: Baseline value to 48 hours after first study drug administration
measure: Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores
timeFrame: Baseline value to 12 hours after first study drug administration
measure: Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores
timeFrame: Baseline value to 24 hours after first study drug administration
measure: Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores
timeFrame: Baseline value to 48 hours after first study drug administration
measure: Time to First Rescue Medication
timeFrame: up to 48 hours
measure: Time to Perceptible Pain Relief
timeFrame: up to 48 hours
measure: Time to Meaningful Pain Relief
timeFrame: up to 48 hours
measure: Pharmacokinetic Concentrations of Tapentadol
timeFrame: 15 minutes to 20 hours after first drug administration
measure: Pharmacokinetic Concentrations of Tapentadol-O-glucuronide
timeFrame: 15 minutes to 20 hours after first drug administration
measure: Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants
timeFrame: Baseline; for the first 6 administrations
measure: Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants
timeFrame: Baseline; for the first 6 administrations
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
References: