Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Premier Research | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A. CNS 7056 | Drug | Initial low dose plus supplemental doses as necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to Ready for Discharge |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| HOPE Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26363333 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Remimazolam 8.0/3.0 mg | Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance |
| FG001 | Remimazolam 7.0/2.0 mg | Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| B. CNS 7056 | Drug | Initial intermediate dose plus supplemental doses as necessary. |
|
|
| C. CNS 7056 | Drug | Initial high dose plus supplemental doses as necessary. |
|
|
| D. Midazolam | Drug | Initial standardized dose plus supplemental doses as necessary. |
|
|
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 |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| ACRI Phase I LLC | Anaheim | California | 92801 | United States |
| Advanced Clinical Research Associates | Anaheim | California | 92801 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| FG002 | Remimazolam 5.0/3.0 mg | Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance |
| FG003 | Midazolam 2.5/1.0 | Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1.0 mg top-ups for sedation maintenance. |
| Safety Population | Safety population included all randomized patients who received any amount of study drug |
|
| Intention to Treat (ITT) Population | Received any amount of study drug, started the procedure, and had at least 1 efficacy assessment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Analysis Population is the Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Remimazolam 8.0/3.0 mg | Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance |
| BG001 | Remimazolam 7.0/2.0 mg | Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance |
| BG002 | Remimazolam 5.0/3.0 mg | Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance |
| BG003 | Midazolam 2.5/1.0 | Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analysis Population is the ITT Population | Posted | Count of Participants | Participants | 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 | Analysis Population is the ITT Population | Posted | Mean | Standard Deviation | minutes | 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 | Analysis Population is the ITT Population | Posted | Mean | Standard Deviation | minutes | After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9 |
|
Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug until Day 4 ± 3 days, and were followed until resolution of any ongoing TEAE up to 30 days
Total number of participants affected with Other (Not Including Serious) Adverse Events represents overall number of participants with non-serious TEAEs reported with a threshold of 5% in any of the arms
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remimazolam 8.0/3.0 mg | Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance | 0 | 40 | 0 | 40 | 10 | 40 |
| EG001 | Remimazolam 7.0/2.0 mg | Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance | 0 | 40 | 0 | 40 | 8 | 40 |
| EG002 | Remimazolam 5.0/3.0 mg | Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance | 0 | 40 | 0 | 40 | 9 | 40 |
| EG003 | Midazolam 2.5/1.0 | Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance. | 0 | 41 | 0 | 41 | 6 | 41 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 11.0 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 |
| ||
| Headache | Nervous system disorders | MedDRA 11.0 |
| ||
| Hypertension | Vascular disorders | MedDRA 11.0 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 11.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA 11.0 |
|
At least 60 days prior to submission for publication, presentation or use, sponsor shall review and comment any proposed oral or written publication, which period may be extended for an additional 30 days. To seek patent protection, sponsor shall have the right to delay the proposed publication for an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Information | PAION UK Ltd | reg_paion@paion.com |
| ID | Term |
|---|---|
| C522201 | remimazolam |
Not provided
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|