Trial Outcomes & Findings for Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) (NCT NCT00562159)

A total of 439 participants were randomized at a total of 62 sites (53 sites from US; 9 sites from Canada) to treatment assignment, and 438 participants received at least one dose of study medication: 213 participants received SCH 697243 and 225 received placebo.

Thirty five participants from the observation year did not continue on to the treatment year; 14 participants were not eligible and 21 participants were screen failures.

Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)

The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication.

The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18.

The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score \>= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication.

The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment.