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Completed

NCT Number: NCT01335724

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.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NCH investigative site, Cologne, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac diethylamine 1.16% gel

Drug

Diclofenac diethylamine 1.16% gel

Placebo Gel

Drug

Placebo gel

Primary outcomes

  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 outcomes

  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"

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2011
Registry last updated
Jul 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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