Intravenous Tapentadol in Post-Bunionectomy Pain

Grünenthal

Status and phase: Completed; Phase 2

Conditions: Bunion; Pain

Treatments: Drug: Tapentadol; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435577

295054

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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177 participants in 2 patient groups, including a placebo group

Tapentadol intravenous

Experimental group

Description:

Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.

Treatment:

Drug: Tapentadol

Matching placebo intravenous

Placebo Comparator group

Description:

Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.

Treatment:

Drug: Matching Placebo