Evidence map›Paper›PMID 26240742›Full record

ArticleTherapeutic advances in drug safety2015

A randomized, crossover, placebo-controlled clinical trial to assess the sensitivity of the CRCDS Mini-Sim to the next-day residual effects of zopiclone.

Arthur A Simen, Cynthia Gargano, Jang-Ho Cha, Melissa Drexel, An Bautmans, Ingeborg Heirman, Tine Laethem, Thomas Hochadel, Lien Gheyle, Kim Bleys and 4 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Therapeutic advances in drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01209728 (A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.1field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01209728 phase1completednot on this map

A Randomized Clinical Trial to Study the Effects of Simulated Driving on Primary Insomniacs

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2010 to 2011Enrolled76ConditionsInsomniaArmsPlacebo/ethanol (blinded)
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 2 countries.

Arthur A SimenMerck Research Laboratories, Merck Sharp & Dohme, North Wales, PA 19454, USA. Present address: Pfizer Worldwide Research & Development, Cambridge, MA 02139, USA.
Cynthia GarganoJohnson & Johnson, Springhouse, PA 19477.
Jang-Ho ChaMerck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
Melissa DrexelMerck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
An BautmansMerck ESD EU, MSD Europe Inc., Belgium.
Ingeborg HeirmanMerck ESD EU, MSD Europe Inc., Belgium.
Tine LaethemMerck ESD EU, MSD Europe Inc., Belgium.
Thomas HochadelCognitive Research Corporation, Saint Petersburg, FL, USA.
Lien GheyleSGS Life Science Services, Antwerp, Belgium.
Kim BleysSGS Life Science Services, Antwerp, Belgium.
Chan BealsMerck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
Aubrey StochMerck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
Gary G KayCognitive Research Corporation, Saint Petersburg, FL, USA.
Arie StruykMerck Research Laboratories, Merck Sharp & Dohme, North Wales, PA, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USMSD (Belgium) · BECognitive Research (United States) · USPfizer (United States) · USSpringhouse · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesWe sought to validate Cognitive Research Corporation's Driving Simulator (CRCDS Mini-Sim) for studies of drug safety with respect to driving ability.

methodsA total of 30 healthy subjects were randomized to receive placebo or 7.5 mg zopiclone, a hypnotic known to impair driving, in random order during the 2 treatment periods of a 2 period crossover design.

resultsEvening administration of 7.5 mg zopiclone increased next-day standard deviation of lateral lane position (SDLP) by 2.62 cm on average compared with evening administration of placebo, and caused significant effects on symmetry analysis. The magnitude of the change in SDLP is highly similar to changes previously observed using on-the-road driving methods.

conclusionsFurther validation of the CRCDS Mini-Sim is warranted to develop this platform for drug safety studies.

Indexed as

cognitiondriving simulationhypnoticsnext-day residual drug effectsstandard deviation of lane position

Identifiers

PMID26240742
PMCPMC4519739
OpenAlexW2163405763

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.