Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection

NCT01257126 | Withdrawn Phase 4

• 1 other identifier: CCAT458CMX01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.

Conditions

Upper Respiratory Tract Infections

Keywords

Upper respiratory tract infections; diclofenac potassium; nimesulide; fever; pain

Outcome Measures

Primary Outcomes (1)

• Reduction of fever as measured by axillary temperature

  120 minutes

Secondary Outcomes (1)

• Reduction of pain as measured by visual analog scale

  120 minutes

Study Arms (2)

diclofenac potassium

EXPERIMENTAL

Drug: diclofenac potassium

nimesulide

ACTIVE COMPARATOR

Drug: nimesulide

Interventions

diclofenac potassium DRUG

diclofenac potassium

nimesulide DRUG

nimesulide

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children who present community acquired, non-complicated, upper respiratory tract infection: rhino-sinusitis, pharyngitis, tonsillitis, ear infection or the combination of these.
• Child must present axillary temperature ≥ 37.5°C.

You may not qualify if:

• Prior history of allergic reaction to the components of the study medication.
• Use of any NSAID or pharmacologic agent in the 24 hours prior to visit 1.
• Subjects who, in the opinion of the investigator, have developed, or are at risk of developing, a complicated infection and are not suitable subjects for the purposes of the study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Respiratory Tract Infections; Fever; Pain

Interventions

Diclofenac; nimesulide

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: April 26, 2012

Record last verified: 2012-04