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Sponsored by: |
Paion UK Ltd. |
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Information provided by: | Paion UK Ltd. |
ClinicalTrials.gov Identifier: | NCT00869440 |
The purpose of this study is to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
Condition | Intervention | Phase |
---|---|---|
Procedural Sedation Endoscopy |
Drug: CNS 7056 Drug: Midazolam |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IIa, Randomized, Controlled, Double-Blind, Dose-Finding Study Evaluating the Safety and Pharmacodynamics of CNS 7056 in Patients Undergoing Diagnostic Upper GI Endoscopy |
Estimated Enrollment: | 100 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CNS 7056 0.10 mg/kg
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Drug: CNS 7056
Administered as a single intravenous injection by a syringe driver over 1 minute
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2: Experimental
CNS 7056 0.15 mg/kg
|
Drug: CNS 7056
Administered as a single intravenous injection by a syringe driver over 1 minute
|
3: Experimental
CNS 7056 0.20 mg/kg
|
Drug: CNS 7056
Administered as a single intravenous injection by a syringe driver over 1 minute
|
4: Experimental
Midazolam 0.075 mg/kg
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Drug: Midazolam
Administered as a single intravenous injection by a syringe driver over 1 minute
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This is a randomized, double-blind, parallel-group, dose-finding study assessing the safety and efficacy of three dose levels of CNS 7056 compared with midazolam in patients undergoing diagnostic upper GI endoscopy.
Patients who meet all study entry criteria and complete screening procedures will be randomly assigned to 1 of 4 treatment groups: CNS 7056 0.10 mg/kg,0.15 mg/kg, or 0.20 mg/kg; or midazolam 0.075 mg/kg. Patients will receive their assigned treatment administered as a single intravenous injection by a syringe driver over 1 minute. The endoscopy will be started when a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of ≤3 has been reached, but no earlier than 90 seconds after Time 0 (the start of study drug injection). Rescue with sedative medication (midazolam 1-2 mg) will be permitted at the discretion of the administering physician.
Efficacy assessments will consist of the MOAA/S scores, Aldrete scores, and drowsiness measures using a Visual Analogue Scale (VAS). Cognitive function will be assessed by the HVLT-R™ and memory for the procedure by the Brice Questionnaire.
Safety assessments will include adverse events, physical examinations, vital signs, ECGs, pulse oximetry measurements, clinical laboratory tests, and pain on injection using a VAS.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients in whom management of airway is judged to be difficult due to:
Contact: Jim Lees | 44 1223 266-406 | j.lees@paion.com |
United States, California | |
Advanced Clinical Research Institute | |
Anaheim, California, United States, 92801 | |
United States, Florida | |
Miami Research Associates | |
South Miami, Florida, United States, 33143 |
Study Director: | James P Lees, B.Sc. MedSci | Paion UK Ltd. |
Responsible Party: | Paion UK Ltd. ( Jim Lees, Clinical Development Manager ) |
Study ID Numbers: | CNS 7056-003 |
Study First Received: | March 25, 2009 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00869440 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CNS 7056 Procedural Sedation Sedation Endoscopy |
Signs and Symptoms Midazolam |