Bunion - Clinical trial details 

Recruitment status:

Not recruiting

Primary Sponsor:

Grünenthal GmbH

Recruitment countries:

United States

Health condition studied:

Bunion

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: Matching Placebo
Drug: Tapentadol

Key inclusion and exclusion 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

• Age minimum: 18 Years
• Age maximum: 65 Years
• Gender: Both

Primary outcomes:

Sum of Pain Intensity Differences (SPID 24)

Secondary outcomes:

Patients Global Impression of Change
Sum of Pain Intensity Difference

Target sample size:

128

Study type:

Interventional

Study design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Contacts:

• Name: René Allard
• Address:
• Phone: +49 241-569-3223
• Email: Clinical-Trials@grunenthal.com
• Affiliation:

Technical details

Scientific 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.

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT01435577

Secondary ID:

295054

Register:

ClinicalTrials.gov

Date of registration:

15/09/2024

Date of first enrollment:

October 2011

Last refreshed:

20 September 2024