Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections

NCT01019980 | Terminated Phase 4 Results

• 1 other identifier: CVOL458AVE02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.

Conditions

Fever

Keywords

Antipyretics; fever; diclofenac; acetaminophen; children; acute upper respiratory tract infections

Outcome Measures

Primary Outcomes (1)

• The Reduction of Temperature

  2 hours

Secondary Outcomes (4)

• Time to Reach a Reduction of Temperature as 0.5 and 1 °C

  2 hours

• Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours

  6 hours

• Safety of Diclofenac Potassium Therapy in the Study Period

  6 hours

• The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever

  2 hours

Study Arms (2)

Diclofenac potassium

EXPERIMENTAL

Drug: Diclofenac potassium

Acetaminophen

ACTIVE COMPARATOR

Drug: Acetaminophen

Interventions

Diclofenac potassium DRUG

Diclofenac potassium

Diclofenac potassium

Acetaminophen DRUG

Acetaminophen

Acetaminophen

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
• Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study

You may not qualify if:

• History of hypersensitivity to any drugs or excipients of the study
• Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
• Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
• Neurological and hemodynamics disorders
• Evidence of liver or kidney impairment or heart failure
• Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Hospital de niños "J. M. de los Rios", Distrito Metropolitano

Caracas, Venezuela

Location

Ciudad Hospitalaria Enrique Tejera, Valencia

Estado Carabobo, Venezuela

Location

MeSH Terms

Conditions

Fever

Interventions

Diclofenac; Acetaminophen

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 25, 2009
• Study Start: March 1, 2010
• Primary Completion: March 1, 2010
• Last Updated: November 19, 2012
• Results First Posted: November 19, 2012

Record last verified: 2012-10

Locations

VE (2)