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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac diethylamine 1.16% gel | Experimental |
| |
| placebo gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac diethylamine 1.16% gel | Drug | Diclofenac diethylamine 1.16% gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Neck Disability Index | Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst" |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCH investigative site | Cologne | Germany | ||||
| NCH investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23964752 | Derived | Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013 Aug 21;14:250. doi: 10.1186/1471-2474-14-250. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diclofenac Diethylamine 1.16% Gel | |
| FG001 | Placebo Gel |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diclofenac Diethylamine 1.16% Gel | |
| BG001 | Placebo Gel | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Mean | Standard Deviation | mm | 48 h |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diclofenac Diethylamine 1.16% Gel |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical project Leader | Novartis Consumer Health | +41223635528 |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000614065 | diclofenac diethylamine |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo gel | Drug | Placebo gel |
|
| 96h |
| Essen |
| Germany |
| NCH investigative site | Munich | Germany |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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". | Posted | Mean | Standard Deviation | mm | 96h |
|
|
|
| Secondary | Neck Disability Index | Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst" | Posted | Mean | Standard Deviation | Total Score | 96h |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo Gel | 0 | 36 | 1 | 36 |
Preliminary agreement between Novartis Consumer Health and the investigator