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Trial record 13 of 13 for:    paion

Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy

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ClinicalTrials.gov Identifier: NCT00869440
Recruitment Status : Completed
First Posted : March 26, 2009
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
Conditions Procedural Sedation
Endoscopy
Interventions Drug: CNS 7056
Drug: Midazolam
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Hide Arm/Group Description CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
Period Title: Overall Study
Started 25 25 25 25
Completed 23 24 25 25
Not Completed 2 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Physician Decision             1             1             0             0
Arm/Group Title 1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg Total
Hide Arm/Group Description CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 25 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
37.7  (13.33) 38.8  (14.08) 43.2  (13.95) 44.6  (13.64) 41.1  (13.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
Female
13
  52.0%
13
  52.0%
16
  64.0%
12
  48.0%
54
  54.0%
Male
12
  48.0%
12
  48.0%
9
  36.0%
13
  52.0%
46
  46.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
25 25 25 25 100
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
169.33  (9.603) 168.42  (10.283) 168.97  (7.432) 171.55  (9.650) 169.57  (9.241)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
73.22  (10.583) 75.17  (10.869) 75.13  (11.027) 75.45  (10.099) 74.74  (10.526)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 25 participants 25 participants 25 participants 25 participants 100 participants
25.47  (2.091) 26.43  (2.158) 26.24  (2.725) 25.59  (2.262) 25.93  (2.324)
1.Primary Outcome
Title Success Rates of the Procedure
Hide Description Success of the procedure is a composite endpoint consisting of: 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
All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)
Arm/Group Title 1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Hide Arm/Group Description:
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
Overall Number of Participants Analyzed 25 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
8
  32.0%
14
  56.0%
16
  64.0%
11
  44.0%
2.Secondary Outcome
Title Time to Fully Alert
Hide Description Time to first of 3 consecutive Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scores of 5 following study drug administration in patients who underwent the endoscopy procedure
Time Frame From study drug administration until fully alert criteria are reached
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)
Arm/Group Title 1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Hide Arm/Group Description:
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
Overall Number of Participants Analyzed 25 25 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
11  (10.04) 13.4  (6.51) 12.1  (5.26) 17.2  (16.71)
3.Secondary Outcome
Title Time to Ready for Discharge
Hide Description Time to first of 3 consecutive Aldrete scores ≥9 after the end endoscopy procedure
Time Frame From the end of the endoscopy procedure up to 120 minutes or until 3 consecutive Aldrete scores of ≥9 are reached, whichever occurs first
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received a dose of study drug, underwent the endoscopy procedure, and had at least 1 efficacy assessment (Intent-to-treat population)
Arm/Group Title 1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Hide Arm/Group Description:
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute
Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
Overall Number of Participants Analyzed 25 25 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
14  (9.96) 12.8  (5.96) 11.8  (4.96) 17.2  (12.81)
Time Frame Treatment-emergent adverse events (TEAEs) were collected from Time 0 on Day 1 to the Follow-up Visit on Day 4, and were followed until resolution (with or without sequelae) up to a maximum of 30 days after Time 0.
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 1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Hide Arm/Group Description CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute CNS 7056: Administered as a single intravenous injection by a syringe driver over 1 minute Midazolam: Administered as a single intravenous injection by a syringe driver over 1 minute
All-Cause Mortality
1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1: CNS 7056 0.10 mg/kg 2: CNS 7056 0.15 mg/kg 3: CNS 7056 0.20 mg/kg 4: Midazolam 0.075 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/25 (24.00%)   8/25 (32.00%)   9/25 (36.00%)   10/25 (40.00%) 
Gastrointestinal disorders         
Abdominal pain  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%)  0/25 (0.00%) 
Investigations         
Oxygen saturation decreased  4/25 (16.00%)  5/25 (20.00%)  6/25 (24.00%)  5/25 (20.00%) 
Nervous system disorders         
Dizziness  0/25 (0.00%)  0/25 (0.00%)  0/25 (0.00%)  2/25 (8.00%) 
Headache  2/25 (8.00%)  2/25 (8.00%)  2/25 (8.00%)  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngeolaryngeal pain  1/25 (4.00%)  1/25 (4.00%)  0/25 (0.00%)  2/25 (8.00%) 
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: NCT00869440     History of Changes
Other Study ID Numbers: CNS 7056-003
First Submitted: March 25, 2009
First Posted: March 26, 2009
Results First Submitted: December 14, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019