HealthyPhase 4NCT00645125
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
A Phase 4 study testing cefdinir (Omnicef) and amoxicillin in people with Healthy, run by Abbott at 1 site in United States.
Trial summary
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cefdinir (Omnicef) and amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Feb 2003
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Female or male child age 4 through 8 years in good general health.
- Minimum weight of 16.3 kg (36 lb).
- Willing to comply with appropriate instructions provided to complete the study.
- Written informed consent from parent/legal guardian.
Who cannot join
- Current medical condition, that in the opinion of the Investigator or designee, could interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
- History of allergic reaction to cefdinir, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
- History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
- Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
- Temperature > than 99.2°F.
- Participation in a clinical or marketing research study within the past 3 months.
- Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
- Family member or close friend employed by an advertising agency, market research company and/or a company that processes or manufacturers medical or health care products.
Trial locations and contacts
1 site in 1 country.
About this study
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
Read the detailed description
The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is described here; the primary purpose for the study is to determine whether cefdinir possesses preferred taste and smell characteristics when compared to amoxicillin, a pediatric taste test.
- Conditions
- Healthy
- Being tested
- cefdinir (Omnicef), amoxicillin
- Keywords
- pediatric taste test, antibiotic taste test, cefdinir, amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefdinir (Omnicef)Drug
Also called ABT-198, Omnicef, cefdinir
2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL
amoxicillinDrug
2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: cefdinir (Omnicef) |
| 2 | Active comparator | Not described Receives: Drug: amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste and smell acceptability assessment
Measured: 2 hours
Secondary outcomes (4)
Adverse events assessment
Measured: 72 hours with follow-up to a satisfactory conclusion
Concomitant medications
Measured: 72 hours
Vital signs
Measured: 2 hours
Any clinically abnormal observations
Measured: 2 hours with follow-up to a satisfactory conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJan 2003
- Primary completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645125
- Sponsor's protocol ID
- M02-567
- Status last verified
- Mar 2008
- First submitted
- 22 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
- ClinicalTrials.gov ID
- NCT00645125
- Acronym / sponsor ID
- M02-567
- Conditions
- Healthy
- Keywords
- pediatric taste test, antibiotic taste test, cefdinir, amoxicillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Feb 2003 (actual)
- First posted
- 27 Mar 2008 (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.
To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
Detailed description
The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is described here; the primary purpose for the study is to determine whether cefdinir possesses preferred taste and smell characteristics when compared to amoxicillin, a pediatric taste test.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: cefdinir (Omnicef) |
| 2 | Active comparator | Drug: amoxicillin |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Female or male child age 4 through 8 years in good general health.
- Minimum weight of 16.3 kg (36 lb).
- Willing to comply with appropriate instructions provided to complete the study.
- Written informed consent from parent/legal guardian.
Key exclusion criteria (8 listed)
- Current medical condition, that in the opinion of the Investigator or designee, could interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
- History of allergic reaction to cefdinir, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
- History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
- Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
- Temperature > than 99.2°F.
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 |
|---|---|---|
| cefdinir (Omnicef)Also: ABT-198, Omnicef, cefdinir2.5 ml of strawberry cream flavored oral suspension 125 mg/5 mL | Drug | 1 |
| amoxicillin2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 mL | Drug | 2 |
Primary outcome
Taste and smell acceptability assessment
Time frame: 2 hours
4 secondary outcomes
Adverse events assessment
Time frame: 72 hours with follow-up to a satisfactory conclusion
Concomitant medications
Time frame: 72 hours
Vital signs
Time frame: 2 hours
Any clinically abnormal observations
Time frame: 2 hours with follow-up to a satisfactory conclusion
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 27 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 cefdinir (Omnicef) and amoxicillin in people with Healthy, run by Abbott at 1 site in United States.
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 4 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 27 Mar 2008. 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 United States. 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?
Taste and smell acceptability assessment (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 27 Mar 2008.