Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Phase 4
Completed
- Conditions
- Neck Pain
- Interventions
- Drug: Placebo gel
- Registration Number
- NCT01335724
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
- Male or female subjects, age range 18 and over.
- Patient with acute neck pain meeting baseline pain intensity level and duration
Exclusion Criteria
- Pain medication was taken within the 6 hours that precede randomization.
- Patient with chronic neck pain as defined as pain for 3 months or longer
- Any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
- Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diclofenac diethylamine 1.16% gel Diclofenac diethylamine 1.16% gel - placebo gel Placebo gel -
- Primary Outcome Measures
Name Time Method Pain on Movement 48 h Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".
- Secondary Outcome Measures
Name Time Method Pain at Rest 96h Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".
Neck Disability Index 96h Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst"
Trial Locations
- Locations (1)
NCH investigative site
🇩🇪Munich, Germany