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

NCT ID: NCT01335724

Last Updated: 2012-07-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Diclofenac diethylamine 1.16% gel

Group Type EXPERIMENTAL

Diclofenac diethylamine 1.16% gel

Intervention Type DRUG

Diclofenac diethylamine 1.16% gel

placebo gel

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

Placebo gel

Interventions

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Diclofenac diethylamine 1.16% gel

Diclofenac diethylamine 1.16% gel

Intervention Type DRUG

Placebo gel

Placebo gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NCH investigative site

Cologne, , Germany

Site Status

NCH investigative site

Essen, , Germany

Site Status

NCH investigative site

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23964752 (View on PubMed)

Other Identifiers

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862-P-201

Identifier Type: -

Identifier Source: org_study_id