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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Drug: Placebo gel; Drug: Diclofenac diethylamine 1.16% gel

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • NCH investigative site
  • Essen, Germany
    • NCH investigative site
  • Munich, Germany
    • NCH investigative site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac diethylamine 1.16% gel	Drug: Diclofenac diethylamine 1.16% gel; Diclofenac diethylamine 1.16% gel
Placebo Comparator: placebo gel	Drug: Placebo gel; Placebo gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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"	96h

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): July 18, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 862-P-201