Evidence map›Paper›PMID 17324243›Full record

Trial reportBritish journal of clinical pharmacology2007

Desloratadine dose selection in children aged 6 months to 2 years: comparison of population pharmacokinetics between children and adults.

Samir K Gupta, Bhavna Kantesaria, Christopher Banfield, Zaiqi Wang

Open access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 35 citations in OpenAlex.

  1. Review
  2. Allergic rhinitis: Review of the diagnosis and management: South African Allergic Rhinitis Working Group.South African family practice : official journal of the South African Academy of Family Practice/Primary Care · 2023
    Review
  3. Article
  4. Off-label prescribing for allergic diseases in children.The World Allergy Organization journal · 2014
    Article
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Samir K GuptaSchering-Plough Research Institute, Kenilworth, NJ 07033, USA. samir.gupta@spcorp.com
Bhavna Kantesaria
Christopher Banfield
Zaiqi Wang

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to identify the dose of desloratadine in children aged > or =6 months- < or =2 years that would yield a single-dose target exposure (AUC) comparable with that in adults taking 5 mg desloratadine as syrup.

methodsIn a phase 1, single-dose, open-label, pharmacokinetic study in 58 children aged > or =6 months- <1 year and > or =1 year- < or =2 years were randomly assigned to desloratadine syrup 0.625 mg (1.25 ml) and 1.25 mg (2.5 ml), respectively. Because the volume of blood that could be collected from individual subjects was limited, a population pharmacokinetic approach was used to estimate the pharmacokinetics of desloratadine. Safety was assessed based on results of screening and postdose physical examinations, laboratory safety tests, vital signs, and adverse events.

resultsThe apparent clearance (CL/F) of desloratadine, population estimate (%CV), in children aged > or =6 months- <1 year was 27.8 l h(-1) (35) and corresponding values in children > or =1 year- < or =2 years was 35.5 l h(-1) (51), compared with 137 l h(-1) (58) for adults. The CL/F ratios (children to adults) indicated that doses of 1 mg for > or =6 months- <1 year and 1.25 mg for > or =1 year- < or =2 years would result in similar systemic exposure to that observed in adults receiving the recommended 5 mg dose. Desloratadine was well tolerated with no safety issues.

conclusionsDoses of 1.0 and 1.25 mg in children aged > or =6 months- < or =2 years should result in an exposure to desloratadine similar to that of adults receiving doses of 5 mg.

Indexed as

Child, PreschoolDose-Response Relationship, DrugDrug Administration ScheduleFemaleHistamine H1 Antagonists, Non-SedatingHumansInfantLoratadineMaledesloratadineHistamine H1 Antagonists, Non-SedatingLoratadine

Identifiers

PMID17324243
PMCPMC2000635
OpenAlexW2038145043

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.