Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upp… (NCT00869440) | Clinical Trial Compass
CompletedPhase 2
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
United States100 participantsStarted 2009-03
Plain-language summary
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male and female patients, aged 18 to 65 years inclusive, scheduled to undergo diagnostic upper GI endoscopy.
* American Society of Anesthesiologists Physical Status (ASA PS) Score I or II.
* Weight range 60 to 120 kg inclusive.
* Body mass index (BMI) 18 to \< 30 kg/m2.
* Patients with no clinically significant abnormalities in 12 lead ECG recorded at Screening.
* Female with a negative serum human chorionic gonadotropin (hCG) pregnancy test result at Screening and negative urine hCG pregnancy test result on Day 1 before the endoscopy procedure.
* Patients with negative drugs of abuse serum result at Screening and negative drugs of abuse urine result on Day 1 before the endoscopy procedure.
* Patient has a negative serum ethanol test result at Screening and a negative ethanol saliva test result on Day 1 before the endoscopy procedure.
* Patient voluntarily signs and dates an informed consent form (ICF) that is approved by an investigational review board (IRB) prior to the conduct of any study procedure.
* Patient is willing and able to comply with study requirements and return for a Follow up Visit (Visit 3 ± 1 day) after the endoscopy procedure.
Exclusion Criteria:
* Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at the discretion of the investigator.
* Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated.
* Patients with evid…
What they're measuring
1
Success Rates of the Procedure
Timeframe: From start of study drug injection to patient discharge