FeverPhase 4NCT01359020
Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children
A Phase 4 study testing ibuprofen, dipyrone, acetaminophen in people with Fever, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 1 site in Brazil.
Trial summary
The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children. For the efficacy asses were compared: the time to start the action; the action duration; the difference between the basal temperature and the lower temperature in the study… Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Fever
- What is being tested?
- ibuprofen, dipyrone, acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.
Who cannot join
- patients with a bad general heath state
- patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;
- intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;
- moderated or severe dehydration;
- conscience state alteration;
- not capable of ingest oral drugs;
- patients being treated with steroids;
- patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco, 50070-550
About this study
Official title: Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children
The purpose of this study was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.
For the efficacy asses were compared:
- the time to start the action;
- the action duration;
- the difference between the basal temperature and the lower temperature in the study period.
For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.
- Conditions
- Fever
- Being tested
- ibuprofen, dipyrone, acetaminophen
- Keywords
- Fever, Ibuprofen, Acetaminophen, Dipyrone
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofen, dipyrone, acetaminophenDrug
The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | 10 milligram per kilo, oral administration Receives: Drug: ibuprofen, dipyrone, acetaminophen |
| Acetaminophen | Active comparator | 10 milligram per kilo, oral administration Receives: Drug: ibuprofen, dipyrone, acetaminophen |
| Dipyrone | Active comparator | 10 milligram per kilo, oral administration Receives: Drug: ibuprofen, dipyrone, acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antipyretic efficacy
The antipyretic efficacy was assessed comparing the time to the beggining of the action of the drugs, the difference between the final and inicial temperature and time of action.
Measured: Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
Secondary outcomes (1)
Adverse Events
All adverse events were recorded.
Measured: Adverse Events were verified at 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claudia Patrícia DN Moura, Study director, Mantecorp Indústria Química e Farmacêutica Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359020
- Sponsor's protocol ID
- ALI/P/04-1
- Status last verified
- May 2011
- First submitted
- 20 May 2011
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children
- ClinicalTrials.gov ID
- NCT01359020
- Acronym / sponsor ID
- ALI/P/04-1
- Conditions
- Fever
- Keywords
- Fever, Ibuprofen, Acetaminophen, Dipyrone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
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 was to compare the efficacy and tolerability of acetaminophen, dipyrone and ibuprofen to fever control in children.
For the efficacy asses were compared:
- the time to start the action;
- the action duration;
- the difference between the basal temperature and the lower temperature in the study period.
For the tolerability asses all adverse events were recorded, as well as your intensity and the relation to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: ibuprofen, dipyrone, acetaminophen10 milligram per kilo, oral administration |
| Acetaminophen | Active comparator | Drug: ibuprofen, dipyrone, acetaminophen10 milligram per kilo, oral administration |
| Dipyrone | Active comparator | Drug: ibuprofen, dipyrone, acetaminophen10 milligram per kilo, oral administration |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree.
Key exclusion criteria (8 listed)
- patients with a bad general heath state
- patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion;
- intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug;
- moderated or severe dehydration;
- conscience state alteration;
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 |
|---|---|---|
| ibuprofen, dipyrone, acetaminophenThe dosage for the three drugs was the same: 10 milligrams per kilo, oral administration | Drug | Acetaminophen, Dipyrone, Ibuprofen |
Primary outcome
Antipyretic efficacy
Time frame: Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
The antipyretic efficacy was assessed comparing the time to the beggining of the action of the drugs, the difference between the final and inicial temperature and time of action.
1 secondary outcome
Adverse Events
Time frame: Adverse Events were verified at 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
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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.
Claudia Patrícia DN Moura study director
Mantecorp Indústria Química e Farmacêutica Ltda.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibuprofen, dipyrone, acetaminophen in people with Fever, run by Mantecorp Industria Quimica e Farmaceutica Ltd. at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antipyretic efficacy (time frame: Temperature was verified 15, 30, 45 and 60 minutes, 2, 3, 4, 5, 6, 7 and 8 hours after the administration of the drug.). 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 24 May 2011.