NCT00140881 is a Phase 4 clinical trial of MK0476; montelukast sodium in Asthma, sponsored by Organon and Co.

Who is sponsoring NCT00140881?

NCT00140881 is sponsored by Organon and Co.

What drugs are being tested in NCT00140881?

Interventions in NCT00140881: MK0476; montelukast sodium, Comparator: placebo.

Is NCT00140881 still recruiting?

NCT00140881 is currently completed. Last updated 14 August 2024.

Last reviewed 2024-08-14 · How we verify

NCT00140881

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)

Completed Phase 4 Last updated 14 August 2024

What this trial tests

Phase 4 trial testing MK0476; montelukast sodium in Asthma in 220 participants. Completed in 14 February 2003.

Timeline

1 June 2000

Primary endpoint
14 February 2003

14 February 2003

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	220
Start date	1 June 2000
Primary completion	14 February 2003
Estimated completion	14 February 2003

Drugs / interventions tested

MK0476; montelukast sodium — full drug profile →
Comparator: placebo — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Organon and Co — full company profile →

Who can join

Adults 2 to 14, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Anti-leukotriene agents compared to inhaled corticosteroids in the management of recurrent and/or chronic asthma in adults and children.
Chauhan BF, Ducharme FM. · · 2012 · cited 80× · PMID 22592685 · DOI 10.1002/14651858.cd002314.pub3
Packaging and Delivery of Asthma Therapeutics.
Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
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NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Organon and Co trials

Trials by the same sponsor.

NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00140881 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 14 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00140881.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing