Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 70
Updated:1/10/2019
Start Date:May 2010
End Date:October 2010

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A Phase IIb Study Evaluating the Safety and Efficacy of Multiple Doses of CNS 7056 Compared to Midazolam in Patients Undergoing Colonoscopy

The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056
compared with midazolam to maintain suitable sedation levels in patients undergoing
colonoscopy.

This is a double-blind, randomized, parallel group, dose-response study to assess the safety
and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable
sedation levels in patients undergoing colonoscopy.

Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry
measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug
and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale,
and monitoring of adverse events.

Inclusion Criteria:

- Male and female patients, aged 18 to 70 years inclusive, scheduled to undergo a
standard colonoscopy.

- American Society of Anesthesiologists Physical Status (ASA PS) Score I, II, or III.

- Weight range 55 to 130 kg inclusive.

- Body mass index (BMI) range 18 to 33 kg/m2 inclusive

- Patients of child-bearing potential and their partners must have been willing to use
adequate contraception such as an intrauterine device, diaphragm or condom during the
study and until 1 month after the last study drug administration. Childbearing
potential was defined as "all patients unless they were a female post menopausal for
at least 2 years, or were surgically sterile."

- Patient voluntarily signed and dated an ICF that was approved by an IRB prior to the
conduct of any study procedure.

- Patient was willing and able to comply with study requirements and return for a Follow
up Visit (Day 4 ± 3 day) after the colonoscopy.

Exclusion Criteria:

- Expected duration of colonoscopy > 30 minutes.

- Patients with a suspected or diagnosed pathology of the lower GI tract that would have
added to the risk of colonoscopy, such as strictures, active inflammatory bowel
disease.

- ASA III patients with history of sleep apnea.

- ASA III patients with obesity (BMI ≥ 30 kg/m2).

- Patients with evidence of uncontrolled renal, hepatic, central nervous system,
respiratory, cardiovascular or metabolic dysfunction, or other clinically significant
(CS) findings at screening that, in the investigator's or medical monitor's opinion,
should have excluded them from the study.

- Patients with clinically significant abnormalities in 12 lead ECG recorded at
screening.

- Female patients with a positive serum human chorionic gonadotropin (HCG) pregnancy
test at screening or baseline.

- Lactating female patients.

- Patients with positive drugs of abuse screen at baseline.

- Patients with positive serum ethanol at baseline.

- Patient with a history of drug or ethanol abuse.

- Patients in receipt of any investigational drug within 30 days or less than 7 half
lives (whichever was longer) before the start of the study, or scheduled to receive
one during the study period.

- Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone,
or a medical condition such that these agents were contraindicated.

- Patients with an inability to communicate well with the investigator.

- Patients in whom management of airway was judged to be difficult due to, e.g.,
thyro-mental distance ≤ 4 cm ("short neck"), or Mallampati score of 4.
We found this trial at
9
sites
6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Anaheim, California 92801
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Anaheim, CA
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Anaheim, California 92801
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Charlottesville, Virginia 22911
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Charlottesville, VA
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Phoenix, Arizona 85050
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Phoenix, AZ
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Raleigh, NC
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Sheffield, Alabama 35660
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Sheffield, AL
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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Stony Brook, NY
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Tulsa, Oklahoma 74137
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Tulsa, OK
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