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

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145222
• Other study ID #: CNS 7056-004
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: December 2018
• Source: Paion UK Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• A. CNS 7056
Initial low dose plus supplemental doses as necessary.
• B. CNS 7056
Initial intermediate dose plus supplemental doses as necessary.
• C. CNS 7056
Initial high dose plus supplemental doses as necessary.
• D. Midazolam
Initial standardized dose plus supplemental doses as necessary.

Locations

Country	Name	City	State
United States	ACRI Phase I LLC	Anaheim	California
United States	Advanced Clinical Research Associates	Anaheim	California
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	HOPE Research Institute	Phoenix	Arizona
United States	Wake Research Associates	Raleigh	North Carolina
United States	Helen Keller Hospital	Sheffield	Alabama
United States	Miami Research Associates	South Miami	Florida
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Options Health Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Paion UK Ltd.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pambianco DJ, Borkett KM, Riff DS, Winkle PJ, Schwartz HI, Melson TI, Wilhelm-Ogunbiyi K. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):984-92. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rates of the Procedure	Success of the procedure is a composite endpoint consisting of: Modified Observer's Assessment for Alertness/Sedation (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	From start of study drug injection to patient discharge
Secondary	Time to Fully Alert	Time to first of 3 consecutive MOAA/S scores of 5 after the last injection of double-blind study medication	From last injection of double-blind study medication until fully alert criteria are reached
Secondary	Time to Ready for Discharge	Time of the first of 3 consecutive Aldrete scores = 9	After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores = 9