Neck Pain
Conditions
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.
Interventions
Diclofenac diethylamine 1.16% gel
DRUGPlacebo gel
Placebo gel
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Diethylamine 1.16% Gel | 36 |
| Placebo Gel | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Placebo Gel | Diclofenac Diethylamine 1.16% Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 36 Participants | 70 Participants |
| Age Continuous | 37.8 years STANDARD_DEVIATION 15.2 | 29.8 years STANDARD_DEVIATION 10.5 | 33.8 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment Germany | 36 participants | 36 participants | 72 participants |
| Sex: Female, Male Female | 14 Participants | 19 Participants | 33 Participants |
| Sex: Female, Male Male | 22 Participants | 17 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 1 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 |
Outcome results
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.
Time frame: 48 h
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Diethylamine 1.16% Gel | Pain on Movement | 19.5 mm | Standard Deviation 12.9 |
| Placebo Gel | Pain on Movement | 56.9 mm | Standard Deviation 16.1 |
Secondary
Neck Disability Index
Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst
Time frame: 96h
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Diethylamine 1.16% Gel | Neck Disability Index | 2.8 Total Score | Standard Deviation 3 |
| Placebo Gel | Neck Disability Index | 14.6 Total Score | Standard Deviation 6.8 |
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.
Time frame: 96h
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Diethylamine 1.16% Gel | Pain at Rest | 1.2 mm | Standard Deviation 2.9 |
| Placebo Gel | Pain at Rest | 19.2 mm | Standard Deviation 11.9 |