drugset / Trial / NCT00562159
Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED)
RandomizedParallel-groupTriple-blindTreatment
Summary
This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
Timeline
- Start
- 2007-11
- Primary completion
- 2009-09
- Completion
- 2009-09
Outcome
Met primary endpoint
registry analysis (superiority or other test); SCH 697243 vs Placebo; p =0.005; Mean Difference (Final Values) -1.31 (95% CI -2.22 to -0.40); ANOVA NCT00562159 ↗
Publications
- Results Nelson HS, Nolte H, Creticos P, Maloney J, Wu J, Bernstein DI. Efficacy and safety of timothy grass allergy immunotherapy tablet treatment in North American adults. J Allergy Clin Immunol. 2011 Jan;127(1):72-80, 80.e1-2. doi: 10.1016/j.jaci.2010.11.035.
- Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SCH 697243 | Other / unclassified | 2800 unknown | Other |
| Background | Fluticasone propionate | Other / unclassified | 44 ug | Inhaled |
| Background | Loratadine | Small molecule | 10 mg | Oral |
| Background | Mometasone | Other / unclassified | 50 ug | Intranasal |
| Background | Olopatadine | Other / unclassified | 0.1 % | Other |
| Background | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |
| Background | Salbutamol | Unknown | 108 ug | Inhaled |