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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01335724
First received: April 13, 2011
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Neck Pain
Drug: Diclofenac diethylamine 1.16% gel
Drug: Placebo gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pain on Movement [ Time Frame: 48 h ] [ Designated as safety issue: No ]
    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:
  • Pain at Rest [ Time Frame: 96h ] [ Designated as safety issue: No ]
    Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

  • Neck Disability Index [ Time Frame: 96h ] [ Designated as safety issue: No ]
    Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst"


Enrollment: 72
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335724

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

No publications provided by Novartis

Additional 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
Study First Received: April 13, 2011
Results First Received: May 11, 2012
Last Updated: June 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 02, 2014