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Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00869440
Recruitment Status : Completed
First Posted : March 26, 2009
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Paion UK Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Procedural Sedation Endoscopy Drug: CNS 7056 Drug: Midazolam Phase 2

Detailed Description:

This was a randomized, double-blind, parallel-group, dose-finding study assessing the safety and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing diagnostic upper GI endoscopy.

Patients who met all study entry criteria and completed screening procedures were randomly assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or midazolam 0.075 mg/kg. Patients received their assigned treatment administered as a single intravenous injection by a syringe driver over 1 minute. The endoscopy started when a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached, but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with sedative medication (midazolam 1-2 mg) was be permitted at the discretion of the administering physician.

Efficacy assessments consisted of the MOAA/S scores, Aldrete scores, and drowsiness measures using a Visual Analogue Scale (VAS). Cognitive function was assessed by the Hopkins Verbal Learning Test-Revised™ (HVLT-R™) and memory for the procedure by the Brice Questionnaire.

Safety assessments included adverse events, physical examinations, vital signs, ECGs, pulse oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Randomized, Controlled, Double-Blind, Dose-Finding Study Evaluating the Safety and Pharmacodynamics of CNS 7056 in Patients Undergoing Diagnostic Upper GI Endoscopy
Study Start Date : March 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: 1: Remimazolam (CNS 7056) 0.10 mg/kg
Remimazolam (CNS 7056) 0.10 mg/kg iv
Drug: CNS 7056
Administered as a single intravenous injection by a syringe driver over 1 minute
Other Name: remimazolam

Experimental: 2: Remimazolam (CNS 7056) 0.15 mg/kg
Remimazolam (CNS 7056) 0.15 mg/kg iv
Drug: CNS 7056
Administered as a single intravenous injection by a syringe driver over 1 minute
Other Name: remimazolam

Experimental: 3: Remimazolam (CNS 7056) 0.20 mg/kg
Remimazolam (CNS 7056) 0.20 mg/kg iv
Drug: CNS 7056
Administered as a single intravenous injection by a syringe driver over 1 minute
Other Name: remimazolam

Experimental: 4: Midazolam 0.075 mg/kg
Midazolam 0.075 mg/kg iv
Drug: Midazolam
Administered as a single intravenous injection by a syringe driver over 1 minute
Other Name: Versed




Primary Outcome Measures :
  1. Success Rates of the Procedure [ Time Frame: From start of study drug injection to patient discharge ]
    Success of the procedure is a composite endpoint consisting of: MOAA/S scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation


Secondary Outcome Measures :
  1. Time to Fully Alert [ Time Frame: From study drug administration until fully alert criteria are reached ]
    Time to first of 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 following study drug administration in patients who underwent the endoscopy procedure

  2. Time to Ready for Discharge [ Time Frame: From the end of the endoscopy procedure up to 120 minutes or until 3 consecutive Aldrete scores of ≥9 are reached, whichever occurs first ]
    Time to first of 3 consecutive Aldrete scores ≥9 after the end endoscopy procedure



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor.
  • Patients taking an agent that inhibits cytochrome P450 subtype 3A4 (CYP3A4) or patients who have taken such an agent within 14 days prior to study start or within the duration of 7 half lives of the drug, whichever is longer.
  • Patients in receipt of any investigational drug within 30 days or less than 7 half lives (whichever is longer) before the start of the study, or scheduled to receive one during the study period.
  • Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
  • Has known or suspected history of alcoholism or drug abuse or misuse within 2 years of Screening or evidence of tolerance or physical dependence before dosing with study drug.
  • Patients with clinically significant findings at Screening that, in the investigator's opinion, should exclude them from the study.
  • Patients with a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV).
  • Patients with an inability to communicate well in English with the investigator.
  • Lactating female patients.
  • Patients in whom management of airway is judged to be difficult due to:

    • obesity (weight > 120 kg, or BMI ≥ 30 kg/m2),
    • thyro mental distance ≤ 4 cm ("short neck"), or
    • Mallampati score of 4 (Appendix IV).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869440


Locations
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United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Paion UK Ltd.
Premier Research Group plc

Publications of Results:
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Responsible Party: Paion UK Ltd.
ClinicalTrials.gov Identifier: NCT00869440     History of Changes
Other Study ID Numbers: CNS 7056-003
First Posted: March 26, 2009    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paion UK Ltd.:
CNS 7056
Procedural Sedation
Sedation
Endoscopy

Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action