deltatrials
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

Updated 8 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 8 times since 2007, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in participants aged 5 to \<18 years of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual tablet or placebo. Open-label rescue medications for the rhinoconjunctivitis and asthma symptoms will be provided. Participants will visit the study site for at least 12 visits. A total of 10 allergic symptoms, 6 rhinoconjunctivitis and 4 lung symptoms, will be recorded daily on an electronic diary by the participant/parent/guardian. The start and end of the grass pollen season (GPS) was determined based on the regional grass pollen count, and lasted up to 162 days. For each region, the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of ≥ 10 grains/m\^3, to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count ≥ 10 grains/m\^3, inclusively.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in participants aged 5 to \<18 years of either sex, and of any race with a history of grass pollen induced rhinoconjunctivitis with or without asthma. While receiving treatment, participants will receive either grass sublingual tablet or placebo. Open-label rescue medications for the rhinoconjunctivitis and asthma symptoms will be provided. Participants will visit the study site for at least 12 visits. A total of 10 allergic symptoms, 6 rhinoconjunctivitis and 4 lung symptoms, will be recorded daily on an electronic diary by the participant/parent/guardian.

The start and end of the grass pollen season (GPS) was determined based on the regional grass pollen count, and lasted up to 162 days. For each region, the GPS is defined as the first day of 3 consecutive recorded days with a grass pollen count of ≥ 10 grains/m\^3, to the last day of the last occurrence of 3 consecutive recorded days with a grass pollen count ≥ 10 grains/m\^3, inclusively.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~May 2017 · 3 months · monthly snapshotCompleted~May 2017 – ~Jun 2018 · 13 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Present [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 3 earlier versions
  1. May 2017 — Jun 2018 [monthly]

    Completed PHASE3

  2. Feb 2017 — May 2017 [monthly]

    Completed PHASE3

  3. 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.