Neck Pain Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Verified date | June 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | NCH investigative site | Cologne | |
Germany | NCH investigative site | Essen | |
Germany | NCH investigative site | Munich |
Lead Sponsor | Collaborator |
---|---|
Novartis |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain on Movement | Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain". | 48 h | No |
Secondary | Pain at Rest | Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain". | 96h | No |
Secondary | Neck Disability Index | Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst" | 96h | No |
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