Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335724
• Other study ID #: 862-P-201
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2011
• Last updated: June 14, 2012
• Start date: April 2011
• Est. completion date: July 2011

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Drug:
• Diclofenac diethylamine 1.16% gel
Diclofenac diethylamine 1.16% gel
• Placebo gel
Placebo gel

Locations

Country	Name	City	State
Germany	NCH investigative site	Cologne
Germany	NCH investigative site	Essen
Germany	NCH investigative site	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

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