drugset / Trial / NCT00671294
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.
RandomizedCrossoverQuadruple-blindTreatment
Summary
This purpose of this study is to assess the efficacy and safety of Ramelteon, once daily (QD), in elderly subjects with chronic insomnia.
Timeline
- Start
- 2002-10
- Primary completion
- 2003-07
- Completion
- 2003-07
Outcome
Met primary endpoint
paper ramelteon 4 mg and 8 mg compared to placebo (28.7 min vs. 38.4 min, p < 0.001; 30.8 min vs. 38.4 min, p = 0.005 PMID 17519067 ↗
Publications
- Results Roth T, Seiden D, Wang-Weigand S, Zhang J. A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia. Curr Med Res Opin. 2007 May;23(5):1005-14. doi: 10.1185/030079907x178874.
- Results Wang-Weigand S, McCue M, Ogrinc F, Mini L. Effects of ramelteon 8 mg on objective sleep latency in adults with chronic insomnia on nights 1 and 2: pooled analysis. Curr Med Res Opin. 2009 May;25(5):1209-13. doi: 10.1185/03007990902858527.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ramelteon | Unknown | 4 mg | Oral |
| Subject | Ramelteon | Unknown | 8 mg | Oral |