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Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy

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ClinicalTrials.gov Identifier: NCT02532647
Recruitment Status : Completed
First Posted : August 26, 2015
Results First Posted : January 23, 2019
Last Update Posted : January 23, 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: Supportive Care
Condition Colonoscopy
Interventions Drug: Remimazolam
Drug: Midazolam
Drug: Placebo
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Remimazolam Placebo Midazolam
Hide Arm/Group Description Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation. Placebo administered in double-blind manner. Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
Period Title: Overall Study
Started 32 16 31
Safety Population [1] 31 16 30
Completed 31 16 30
Not Completed 1 0 1
Reason Not Completed
Did not receive trial medication             1             0             1
[1]
Safety Population: all randomised patients who received any amount of trial drug
Arm/Group Title Remimazolam Placebo Midazolam Total
Hide Arm/Group Description Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation. Placebo administered in double-blind manner. Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation. Total of all reporting groups
Overall Number of Baseline Participants 31 16 30 77
Hide Baseline Analysis Population Description
Baseline Analysis Population is the Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 16 participants 30 participants 77 participants
63.1  (8.65) 63.0  (8.37) 61.5  (10.60) 62.5  (9.32)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 16 participants 30 participants 77 participants
<65 years
18
  58.1%
9
  56.3%
19
  63.3%
46
  59.7%
≥65 years
13
  41.9%
7
  43.8%
11
  36.7%
31
  40.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 16 participants 30 participants 77 participants
Female
14
  45.2%
4
  25.0%
16
  53.3%
34
  44.2%
Male
17
  54.8%
12
  75.0%
14
  46.7%
43
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 16 participants 30 participants 77 participants
31 16 30 77
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 31 participants 16 participants 30 participants 77 participants
171.1  (10.07) 171.8  (7.72) 168.4  (10.32) 170.2  (9.72)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 31 participants 16 participants 30 participants 77 participants
91.0  (28.14) 94.0  (26.11) 87.9  (23.91) 90.4  (25.90)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 31 participants 16 participants 30 participants 77 participants
30.9  (8.28) 30.8  (5.53) 30.8  (6.75) 30.8  (7.11)
American Society of Anesthesiologists (ASA) Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 16 participants 30 participants 77 participants
ASA Class III
16
  51.6%
9
  56.3%
15
  50.0%
40
  51.9%
ASA Class IV
15
  48.4%
7
  43.8%
15
  50.0%
37
  48.1%
[1]
Measure Description: ASA Class III: Severe systemic disease. ASA Class IV: Severe systemic disease that is constant threat to life
1.Primary Outcome
Title Success Rates of the Procedure
Hide Description The success of the procedure, as measured by completion of the colonoscopy procedure, AND no requirement for a rescue sedative medication, AND no requirement of more than 5 doses of study medication within any 15 minute window. (For midazolam: 3 doses within any 12 minute window)
Time Frame From first dose of study drug until the end of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, and analysed as randomised.
Arm/Group Title Remimazolam Placebo Midazolam
Hide Arm/Group Description:
Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
Placebo administered in double-blind manner.
Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
Overall Number of Participants Analyzed 32 16 31
Measure Type: Count of Participants
Unit of Measure: Participants
27
  84.4%
0
   0.0%
4
  12.9%
2.Secondary Outcome
Title Time to Start of Procedure
Hide Description The time from the first administration of the study drug to the beginning of the colonoscopy
Time Frame From the first administration of the study drug to the beginning of the colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who did not reach the endpoint are excluded from this analysis.
Arm/Group Title Remimazolam Placebo Midazolam
Hide Arm/Group Description:
Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
Placebo administered in double-blind manner.
Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
Overall Number of Participants Analyzed 31 16 30
Median (Inter-Quartile Range)
Unit of Measure: minutes
5.0
(4.0 to 8.0)
18.3
(17.5 to 21.0)
19.0
(19.0 to 19.0)
3.Secondary Outcome
Title Time to Fully Alert
Hide Description Time to first of 3 Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 after the end of colonoscopy procedure (colonoscope out) and after the last injection of study drug
Time Frame From the last injection of the study drug AND from end of colonoscopy until the patient has recovered to fully alert
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who did not reach the endpoint are censored at last observation.
Arm/Group Title Remimazolam Placebo Midazolam
Hide Arm/Group Description:
Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation.
Placebo administered in double-blind manner.
Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
Overall Number of Participants Analyzed 31 16 30
Median (95% Confidence Interval)
Unit of Measure: minutes
After last dose of trial or rescue sedative
11.0
(8.8 to 12.0)
18.0
(14.0 to 25.0)
18.8
(15.0 to 26.0)
After the end of colonoscopy
3.0
(2.0 to 4.0)
5.3
(4.0 to 12.0)
7.0
(4.0 to 12.0)
Time Frame Treatment-emergent Adverse Events (TEAEs) were collected from first dose of study drug medication until Day 4 (+ 3 days), and were followed until events resolved, became stable, or could be explained by another known cause(s)
Adverse Event Reporting Description Total number of participants affected with Other (Not Including Serious) Adverse Events represents any participant in the trial with a TEAE. The number of participants with Preferred Term (PT)TEAEs represents participants with TEAEs reported with a threshold of 5% in any of the arms
 
Arm/Group Title Remimazolam Placebo Midazolam
Hide Arm/Group Description Remimazolam 2.5 - 5.0 mg initially, followed by 1.25 - 2.5 mg top-up doses as required to maintain sedation. Placebo administered in double-blind manner. Midazolam 1.0 mg initially, followed by 0.5 mg top-up doses as required to maintain sedation.
All-Cause Mortality
Remimazolam Placebo Midazolam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/16 (0.00%)   0/30 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Remimazolam Placebo Midazolam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/16 (0.00%)   1/30 (3.33%) 
Blood and lymphatic system disorders       
Anaemia  0/31 (0.00%)  0/16 (0.00%)  1/30 (3.33%) 
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remimazolam Placebo Midazolam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/31 (90.32%)   13/16 (81.25%)   26/30 (86.67%) 
Cardiac disorders       
Bradycardia  1/31 (3.23%)  1/16 (6.25%)  4/30 (13.33%) 
Tachycardia  0/31 (0.00%)  2/16 (12.50%)  0/30 (0.00%) 
Investigations       
Respiratory rate decreased  1/31 (3.23%)  1/16 (6.25%)  2/30 (6.67%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory acidosis  6/31 (19.35%)  2/16 (12.50%)  8/30 (26.67%) 
Vascular disorders       
Hypotension  18/31 (58.06%)  11/16 (68.75%)  17/30 (56.67%) 
Hypertension  13/31 (41.94%)  6/16 (37.50%)  13/30 (43.33%) 
Diastolic hypertension  3/31 (9.68%)  0/16 (0.00%)  0/30 (0.00%) 
Diastolic hypotension  1/31 (3.23%)  1/16 (6.25%)  0/30 (0.00%) 
Systolic hypertension  2/31 (6.45%)  0/16 (0.00%)  0/30 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
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 45 days prior to submission of communications, sponsor shall review and comment on the communications. Sponsor shall have the right to require institution and investigator to remove specifically identified confidential information and to delay the proposed publication an additional 45 days to enable sponsor to seek patent protection
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Information
Organization: PAION UK Ltd
EMail: reg_paion@paion.com
Layout table for additonal information
Responsible Party: Paion UK Ltd.
ClinicalTrials.gov Identifier: NCT02532647     History of Changes
Other Study ID Numbers: CNS7056-015
First Submitted: August 19, 2015
First Posted: August 26, 2015
Results First Submitted: December 14, 2018
Results First Posted: January 23, 2019
Last Update Posted: January 23, 2019