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Trial record 12 of 13 for:    paion

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

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ClinicalTrials.gov Identifier: NCT01145222
Recruitment Status : Completed
First Posted : June 16, 2010
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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Sedation
Interventions Drug: A. CNS 7056
Drug: B. CNS 7056
Drug: C. CNS 7056
Drug: D. Midazolam
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Hide Arm/Group Description Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1.0 mg top-ups for sedation maintenance.
Period Title: Overall Study
Started 40 40 41 41
Safety Population [1] 40 40 40 41
Intention to Treat (ITT) Population [2] 40 40 40 40
Completed 40 40 40 40
Not Completed 0 0 1 1
Reason Not Completed
Procedure not done (no anesthesiologist)             0             0             1             0
Poor bowel preparation             0             0             0             1
[1]
Safety population included all randomized patients who received any amount of study drug
[2]
Received any amount of study drug, started the procedure, and had at least 1 efficacy assessment
Arm/Group Title Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0 Total
Hide Arm/Group Description Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance. Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 41 161
Hide Baseline Analysis Population Description
Baseline Analysis Population is the Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 41 participants 161 participants
54.5  (11.22) 54.5  (8.07) 54.0  (10.30) 55.5  (5.86) 54.6  (9.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 41 participants 161 participants
Female
22
  55.0%
25
  62.5%
22
  55.0%
20
  48.8%
89
  55.3%
Male
18
  45.0%
15
  37.5%
18
  45.0%
21
  51.2%
72
  44.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 40 participants 41 participants 161 participants
40 40 40 41 161
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 40 participants 40 participants 40 participants 41 participants 161 participants
169.15  (11.0) 168.18  (8.3) 169.01  (11.3) 169.87  (10.1) 169.06  (10.2)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 40 participants 40 participants 40 participants 41 participants 161 participants
79.68  (13.4) 76.23  (11.6) 76.79  (14.5) 76.95  (13.6) 77.41  (13.3)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 40 participants 40 participants 40 participants 41 participants 161 participants
27.79  (3.451) 27.02  (4.042) 26.73  (3.063) 26.58  (3.515) 27.03  (3.533)
1.Primary Outcome
Title Success Rates of the Procedure
Hide Description 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
Time Frame From start of study drug injection to patient discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population is the ITT Population
Arm/Group Title Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Hide Arm/Group Description:
Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
37
  92.5%
38
  95.0%
39
  97.5%
30
  75.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Remimazolam 8.0/3.0 mg, Remimazolam 7.0/2.0 mg, Remimazolam 5.0/3.0 mg, Midazolam 2.5/1.0
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Overall comparison between remimazolam and midazolam
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Time to Fully Alert
Hide Description Time to first of 3 consecutive MOAA/S scores of 5 after the last injection of double-blind study medication
Time Frame From last injection of double-blind study medication until fully alert criteria are reached
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population is the ITT Population
Arm/Group Title Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Hide Arm/Group Description:
Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
Overall Number of Participants Analyzed 40 40 40 40
Mean (Standard Deviation)
Unit of Measure: minutes
13.6  (7.48) 11.3  (5.69) 13.3  (7.21) 15.2  (7.43)
3.Secondary Outcome
Title Time to Ready for Discharge
Hide Description Time of the first of 3 consecutive Aldrete scores ≥ 9
Time Frame After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis Population is the ITT Population
Arm/Group Title Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Hide Arm/Group Description:
Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance
Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance
Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance
Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
Overall Number of Participants Analyzed 40 40 40 40
Mean (Standard Deviation)
Unit of Measure: minutes
After last injection 14.6  (8.52) 12.4  (6.72) 11.3  (4.86) 15.3  (8.13)
After end of colonoscopy 5.0  (6.29) 4.6  (4.58) 3.8  (4.16) 5.5  (6.59)
Time Frame 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
Adverse Event Reporting Description 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
 
Arm/Group Title Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Hide Arm/Group Description Double-blind Remimazolam iv arm: 8 mg for sedation induction, and 3 mg top-ups for sedation maintenance Double-blind Remimazolam iv arm: 7 mg for sedation induction, and 2 mg top-ups for sedation maintenance Double-blind Remimazolam iv arm: 5 mg for sedation induction, and 3 mg top-ups for sedation maintenance Double-blind Midazolam iv arm: 2.5 mg for sedation induction, and 1 mg top-ups for sedation maintenance.
All-Cause Mortality
Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/41 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remimazolam 8.0/3.0 mg Remimazolam 7.0/2.0 mg Remimazolam 5.0/3.0 mg Midazolam 2.5/1.0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/40 (25.00%)   8/40 (20.00%)   9/40 (22.50%)   6/41 (14.63%) 
Cardiac disorders         
Bradycardia  3/40 (7.50%)  1/40 (2.50%)  0/40 (0.00%)  0/41 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1/40 (2.50%)  2/40 (5.00%)  3/40 (7.50%)  0/41 (0.00%) 
Vomiting  1/40 (2.50%)  2/40 (5.00%)  3/40 (7.50%)  2/41 (4.88%) 
Nausea  3/40 (7.50%)  2/40 (5.00%)  2/40 (5.00%)  1/41 (2.44%) 
Nervous system disorders         
Headache  1/40 (2.50%)  3/40 (7.50%)  3/40 (7.50%)  2/41 (4.88%) 
Dizziness  0/40 (0.00%)  1/40 (2.50%)  2/40 (5.00%)  0/41 (0.00%) 
Vascular disorders         
Hypertension  3/40 (7.50%)  0/40 (0.00%)  1/40 (2.50%)  4/41 (9.76%) 
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Trial Information
Organization: PAION UK Ltd
Responsible Party: Paion UK Ltd.
ClinicalTrials.gov Identifier: NCT01145222     History of Changes
Other Study ID Numbers: CNS 7056-004
First Submitted: May 27, 2010
First Posted: June 16, 2010
Results First Submitted: December 14, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019