Completed PHASE3 INTERVENTIONAL 2-arm NCT00550550

Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 (Phleum Pratense) in Children 5 to <18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivitis With or Without Asthma

Sponsor: ALK-Abelló A/S

Conditions Allergy Conjunctivitis Rhinitis Rhinoconjunctivitis

Interventions Albuterol 108 mcg Rescue Treatment Fluticasone 44 mcg Rescue Treatment Loratadine 10 mg Rescue Treatment Loratadine Syrup 1 mg/mL Rescue Treatment Mometasone furoate 50 mcg Rescue Treatment Olopatadine 0.1% Rescue Treatment Placebo Prednisone 5 mg Rescue Treatment SCH 697243

Updated 7 times since 2017 Last updated: Jan 18, 2017 Started: Nov 30, 2007 Primary completion: Sep 30, 2009 Completion: Sep 30, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00550550, this PHASE3 trial focuses on Allergy and Conjunctivitis and remains completed. Sponsored by ALK-Abelló A/S, it has been updated 7 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
May 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — May 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Nov 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

ALK-Abelló A/S

Data source: ALK-Abelló A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.