Phase 4
N=72
Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
Neck Pain
Bottom Line
View on ClinicalTrials.gov: NCT01335724 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Pain on Movement — 19.5; 56.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Diclofenac diethylamine 1.16% gel (Drug); Placebo gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on Movement |
19.5; 56.9 | — |
| SECONDARY Pain at Rest |
1.2; 19.2 | — |
| SECONDARY Neck Disability Index |
2.8; 14.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01335724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.