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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01189604 |
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Date of registration:
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25/08/2010 |
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Primary sponsor: |
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Public title:
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Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests
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Scientific title:
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A Multi-centre, Single-blind, Randomised, Parallel Group, Phase IIb Dose Rate Range Finding Study to Find Maintenance Dose Rate Range of ICI35,868 for the Minimal-to-moderate Sedation on Gastrointestinal Endoscopic Tests (Including Endoscopic Polypectomy) |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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123 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01189604 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masataka Date, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Physician Group, Clinical Division, R&D, Astrazeneca K.K. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female (females of child bearing potential to confirm not pregnant via test
or contraception)
- Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy,
including polypectomy that shall be completed within 1 hour
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) grade III, IV V and VI
- Baseline oxygen saturation<90% (room air)
- Body Mass Index (BMI) >=35
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastrointestinal Endoscopy
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Gastrointestinal Polypectomy
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Intervention(s)
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Drug: ICI35,868 (propofol)
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Drug: Placebo
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Primary Outcome(s)
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Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period
[Time Frame: 2 minutes from the beginning of the maintenance period]
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Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period
[Time Frame: 4 minutes from the beginning of the maintenance period]
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Secondary Outcome(s)
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Blood Concentrations of Propofol
[Time Frame: At the end of the initiation period and every 2 minutes during the maintenance period]
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Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period
[Time Frame: Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7)]
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Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire
[Time Frame: 24 - 48 hours after completion of the procedure]
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Secondary ID(s)
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D0092C00001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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