FeverPhase 4NCT01019980
Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
A Phase 4 study testing Diclofenac potassium and Acetaminophen in people with Fever, run by Novartis Pharmaceuticals at 2 sites in Venezuela.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Fever
- What is being tested?
- Diclofenac potassium and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesVenezuela
- Study dates
- Mar 2010to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Venezuela2 sites
Hospital de niños "J. M. de los Rios", Distrito Metropolitano
Caracas
Ciudad Hospitalaria Enrique Tejera, Valencia
Estado Carabobo
About this study
Official title: A Comparative Double Blind, Double Dummy, Randomized Study on the Effectiveness of Diclofenac Potassium vs. Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
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
- Being tested
- Diclofenac potassium, Acetaminophen
- Keywords
- Antipyretics, fever, diclofenac, acetaminophen, children, acute upper respiratory tract infections
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac potassiumDrug
Diclofenac potassium
AcetaminophenDrug
Acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac potassium | Experimental | Not described Receives: Drug: Diclofenac potassium |
| Acetaminophen | Active comparator | Not described Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Reduction of Temperature
Measured: 2 hours
Secondary outcomes (4)
Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Measured: 2 hours
Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Measured: 6 hours
Safety of Diclofenac Potassium Therapy in the Study Period
Measured: 6 hours
The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2010
Why it stopped: Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019980
- Sponsor's protocol ID
- CVOL458AVE02
- Status last verified
- Oct 2012
- First submitted
- 20 Nov 2009
- Last updated
- 19 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Double Blind, Double Dummy, Randomized Study on the Effectiveness of Diclofenac Potassium vs. Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT01019980
- Acronym / sponsor ID
- CVOL458AVE02
- Conditions
- Fever
- Keywords
- Antipyretics, fever, diclofenac, acetaminophen, children, acute upper respiratory tract infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2010 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Posted 19 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac potassium | Experimental | Drug: Diclofenac potassium |
| Acetaminophen | Active comparator | Drug: Acetaminophen |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac potassiumDiclofenac potassium | Drug | Diclofenac potassium |
| AcetaminophenAcetaminophen | Drug | Acetaminophen |
Primary outcome
The Reduction of Temperature
Time frame: 2 hours
4 secondary outcomes
Time to Reach a Reduction of Temperature as 0.5 and 1 °C
Time frame: 2 hours
Time With a Temperature ≤ 38,4 °C in a Period of 6 Hours
Time frame: 6 hours
Safety of Diclofenac Potassium Therapy in the Study Period
Time frame: 6 hours
The Level of Knowledge That Parents or Legal Representatives Have on the Treatment of Fever
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac potassium and Acetaminophen in people with Fever, run by Novartis Pharmaceuticals at 2 sites in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Reduction of Temperature (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2012.