Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain
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
1 other identifier
interventional
72
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 13, 2011
CompletedFirst Posted
Study publicly available on registry
April 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
July 18, 2012
CompletedJuly 18, 2012
June 1, 2012
3 months
April 13, 2011
May 11, 2012
June 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Pain at Rest
96h
Neck Disability Index
96h
Study Arms (2)
Diclofenac diethylamine 1.16% gel
EXPERIMENTALplacebo gel
PLACEBO COMPARATORInterventions
Diclofenac diethylamine 1.16% gel
Eligibility Criteria
You may qualify if:
- Male or female subjects, age range 18 and over.
- Patient with acute neck pain meeting baseline pain intensity level and duration
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (3)
NCH investigative site
Cologne, Germany
NCH investigative site
Essen, Germany
NCH investigative site
Munich, Germany
Related Publications (1)
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.
PMID: 23964752DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical project Leader
- Organization
- Novartis Consumer Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2011
First Posted
April 14, 2011
Study Start
April 1, 2011
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
July 18, 2012
Results First Posted
July 18, 2012
Record last verified: 2012-06