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NCT01209728
Effects of Insomnia on Simulated Driving (MK-0000-183-00)
Phase 1 trial testing Placebo/ethanol (blinded) in Insomnia in 76 participants. Completed in 1 September 2011.
1 September 2011
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 76 |
| Start date | 1 October 2010 |
| Primary completion | 1 September 2011 |
| Estimated completion | 1 September 2011 |
Drugs / interventions tested
- Placebo/ethanol (blinded)
Conditions studied
- Insomnia — all drugs for Insomnia →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
65 and older, any sex, with Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a double-blind, parallel design study in elderly primary insomnia patients and demographically matched controls. The objectives if this study are primarily: 1. To determine if functional deficits in simulated driving performance can be demonstrated in primary insomnia patients, and detected in healthy volunteers, impaired by alcohol; and secondarily: 2. To compare simulated driving performance deficits in elderly primary insomnia patients to those in healthy elderly volunteers impaired by alcohol, for at least one of the following driving endpoints: standard deviation of lane position (SDLP), standard deviation of speed (speed deviation), lane excursions, and a driving composite score.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01209728
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Insomnia
Currently open trials in the same condition.
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- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01209728 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
- Last refreshed: 12 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01209728.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing