Evidence map›Paper›PMID 37402024›Full record

Trial reportClinical pharmacokinetics2023

Pharmacokinetics of Nasal Esketamine in Patients with Allergic Rhinitis with and Without Nasal Decongestant Pretreatment and in Healthy Subjects with and Without Nasal Corticosteroid Pretreatment.

Peter Zannikos, Bhavna Solanki, Marc De Meulder, Philipp Badorrek, Jens M Hohlfeld, Jaskaran Singh

Erratum issued Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02154334 (An Open-label Study to Assess the Effects of Allergic Rhinitis and Coadministration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 42% 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.

NCT02154334 phase1completednot on this map

An Open-label Study to Assess the Effects of Allergic Rhinitis and Coadministration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

TypeinterventionalSponsorJanssen Research & Development, LLCRan2014 to 2014Enrolled47ConditionsAllergic RhinitisArmsEsketamine, Mometasone, Oxymetazoline
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Peter ZannikosJanssen R&D, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA. pnzannikos@gmail.com.ORCID 0000-0001-9444-3862
Bhavna SolankiJanssen R&D, 6050 Paseo Carreta, Carlsbad, CA, 92009, USA.
Marc De MeulderJanssen R&D, Turnhoutseweg 30, Beerse, 2340, Antwerp, Belgium.
Philipp BadorrekClinical Airway Research, Fraunhofer Institute for Toxicology and Experimental Medicine, Feodor-Lynen-Str. 15, 30625, Hannover, Germany.
Jens M HohlfeldDepartment of Respiratory Science, Fraunhofer Institute for Toxicology and Experimental Medicine, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.ORCID 0000-0003-2646-6186
Jaskaran SinghNeurocrine Bioscience, Inc, 12780 El Camino Real, San Diego, CA, 92130, USA.
Fraunhofer Institute for Toxicology and Experimental Medicine · DEJanssen (United States) · USJanssen (Belgium) · BENeurocrine Biosciences (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesNasal esketamine is indicated for the treatment of adults with treatment-resistant depression and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Primary objectives of this study were to evaluate the effect of nasal decongestant pretreatment in patients with allergic rhinitis and the impact of daily nasal corticosteroid administration by healthy subjects on nasal esketamine pharmacokinetics.

methodsPatients with allergic rhinitis self-administered 56 mg of nasal esketamine after pretreatment with nasal oxymetazoline (0.05%) at 1 h before esketamine and without oxymetazoline pretreatment. They were exposed to grass pollen in an allergen challenge chamber to induce allergic rhinitis symptoms at approximately 2 h before each esketamine administration until 1 h after. Healthy subjects self-administered esketamine (56 mg) before and after administration for 16 consecutive days of mometasone (200 µg), with the second esketamine dose administered 1 h after the last mometasone dose. The plasma pharmacokinetics of esketamine and noresketamine were assessed after each esketamine administration. The tolerability of esketamine, including effects on dissociative and potential psychotomimetic symptoms and level of sedation and suicidal ideation and behavior, was evaluated.

resultsThe rate of esketamine absorption was slightly greater in patients exhibiting symptoms of allergic rhinitis (decrease in median t

conclusionsPatients exhibiting symptoms of rhinitis may receive nasal esketamine spray without dose adjustment. In addition, esketamine may be administered 1 h after using a nasal decongestant or corticosteroid.

trial registrationThe study was registered in the Clinical Trials (NCT02154334) and EudraCT (2014-000534-38) registries.

Indexed as

Major Depressive DisorderRhinitis, AllergicAdministration, IntranasalAdrenal Cortex HormonesAdultDouble-Blind MethodHealthy VolunteersHumansMometasone FuroateNasal DecongestantsNasal SpraysOxymetazolineAdrenal Cortex HormonesMometasone FuroateNasal DecongestantsNasal SpraysOxymetazoline

Identifiers

PMID37402024
OpenAlexW4383058873

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.