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

NCT01145222 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CNS 7056-004
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Sedation

Keywords

CNS 7056; Procedural Sedation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to Fully Alert

  From last injection of double-blind study medication until fully alert criteria are reached

• Time to Ready for Discharge

  After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9

Study Arms (4)

A. Remimazolam (CNS 7056)

EXPERIMENTAL

Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses.

Drug: A. CNS 7056

B. Remimazolam (CNS 7056)

EXPERIMENTAL

Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses.

Drug: B. CNS 7056

C. Remimazolam (CNS 7056)

EXPERIMENTAL

Initial 5 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses.

Drug: C. CNS 7056

D. Midazolam

ACTIVE COMPARATOR

Initial 2.5 mg iv for sedation induction, and 1 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses

Drug: D. Midazolam

Interventions

A. CNS 7056 DRUG

Initial low dose plus supplemental doses as necessary.

Also known as: CAS No. 1001415-66-2, Remimazolam

A. Remimazolam (CNS 7056)

B. CNS 7056 DRUG

Initial intermediate dose plus supplemental doses as necessary.

Also known as: CAS No. 1001415-66-2, Remimazolam

B. Remimazolam (CNS 7056)

C. CNS 7056 DRUG

Initial high dose plus supplemental doses as necessary.

Also known as: CAS No. 1001415-66-2, Remimazolam

C. Remimazolam (CNS 7056)

D. Midazolam DRUG

Initial standardized dose plus supplemental doses as necessary.

Also known as: CAS No. 59467-96-8

D. Midazolam

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paion UK Ltd.: lead
• Premier Research: collaborator

Study Sites (9)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85050, United States

Location

ACRI Phase I LLC

Anaheim, California, 92801, United States

Location

Advanced Clinical Research Associates

Anaheim, California, 92801, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Options Health Research

Tulsa, Oklahoma, 74104, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Related 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: 10.1016/j.gie.2015.08.062. Epub 2015 Sep 9.

  PMID: 26363333 RESULT

MeSH Terms

Interventions

remimazolam

Results Point of Contact

• Title: Trial Information
• Organization: PAION UK Ltd

reg_paion@paion.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 16, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 8, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-12

Locations

US (9)