CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,501 enrolled
Drug / intervention
Grass (Phleum pratense) pollen allergen extract +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01385371
NCT01385371Phase 3Completed

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, With a History of Grass Pollen-Induced Rhinoconjunctivitis, With or Without Asthma (Protocol No. P08067)

ALK-Abelló A/S·interventional·Posted Jun 30, 2011·Updated Mar 3, 2017

In Brief

A Phase 3 clinical trial evaluating Grass (Phleum pratense) pollen allergen extract and Placebo for SCH 697243 for Rhinitis Allergic and Conjunctivitis. Completed, enrolled 1,501 participants.

Detailed Summary

This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2011
Enrollment StartJun 1, 2011
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.0 years ago

Interventions

Grass (Phleum pratense) pollen allergen extractbiological

One dissolving tablet sublingually once daily

Placebo for SCH 697243biological

One dissolving tablet sublingually once daily