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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01335724
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : July 18, 2012
Last Update Posted : July 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Neck Pain Drug: Diclofenac diethylamine 1.16% gel Drug: Placebo gel Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2011
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Pain on Movement [ Time Frame: 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 Outcome Measures :
  1. Pain at Rest [ Time Frame: 96h ]
    Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

  2. Neck Disability Index [ Time Frame: 96h ]
    Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst"


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335724


Locations
Germany
NCH investigative site
Cologne, Germany
NCH investigative site
Essen, Germany
NCH investigative site
Munich, Germany
Sponsors and Collaborators
Novartis
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01335724     History of Changes
Other Study ID Numbers: 862-P-201
First Posted: April 14, 2011    Key Record Dates
Results First Posted: July 18, 2012
Last Update Posted: July 18, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action