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

Primary Purpose

Neck Pain

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Diclofenac diethylamine 1.16% gel

Placebo gel

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NCH investigative site
NCH investigative site
NCH investigative site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac diethylamine 1.16% gel

placebo gel

Arm Description

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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".

Neck Disability Index

Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst"

Full Information

NCT ID

NCT01335724

First Posted

April 13, 2011

Last Updated

June 14, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT01335724

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diclofenac diethylamine 1.16% gel

Arm Type

Experimental

Arm Title

placebo gel

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Diclofenac diethylamine 1.16% gel

Intervention Description

Diclofenac diethylamine 1.16% gel

Intervention Type

Drug

Intervention Name(s)

Placebo gel

Intervention Description

Placebo gel

Primary Outcome Measure Information:

Title

Pain on Movement

Description

Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

Time Frame

48 h

Secondary Outcome Measure Information:

Title

Pain at Rest

Description

Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

Time Frame

96h

Title

Neck Disability Index

Description

Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst"

Time Frame

96h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

NCH investigative site

City

Cologne

Country

Germany

Facility Name

NCH investigative site

City

Essen

Country

Germany

Facility Name

NCH investigative site

City

Munich

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

23964752

Citation

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.

Results Reference

derived

Learn more about this trial

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

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