Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johnson & Johnson K.K. Medical Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 - Placebo | Placebo Comparator |
| |
| Arm 2 - ICI35,868 (propofol) | Active Comparator |
| |
| Arm 3 - ICI35,868 (propofol) | Active Comparator |
| |
| Arm 4 - ICI35,868 (propofol) | Active Comparator |
| |
| Arm 5 - ICI35,868 (propofol) | Active Comparator |
| |
| Arm 6 - ICI35,868 (propofol) | Active Comparator |
| |
| Arm 7 - ICI35,868 (propofol) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Infusion of placebo, same infusion rates as for arm 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5. | 2 minutes from the beginning of the maintenance period |
| Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5. | 4 minutes from the beginning of the maintenance period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied). | 24 - 48 hours after completion of the procedure |
| Blood Concentrations of Propofol |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Masataka Date, M.D., Ph.D. | Physician Group, Clinical Division, R&D, Astrazeneca K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Isesaki | Gunma | Japan | |||
| Research Site |
The patients enrolled in this study were undergoing non-emergent standard esophagogastroduodenoscopy (EGD) or colonoscopy. Six patients were withdrawn from the study after enrollment but before randomization: 5 patients due to excess recruitment and one patient due to investigator's recommendation..
A total of 2 centers were initiated with first patient enrolled on 23 August 2010 and last patient completed on 17 November. A total of 129 patients were enrolled with 123 qualified patients allocated to randomized treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Placebo | Infusion of placebo, same infusion rates as for arm 2 |
| FG001 | Arm 2 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ICI35,868 (propofol) |
| Drug |
Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute |
|
| ICI35,868 (propofol) | Drug | Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute |
|
| ICI35,868 (propofol) | Drug | Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute |
|
| ICI35,868 (propofol) | Drug | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute |
|
| ICI35,868 (propofol) | Drug | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
|
| ICI35,868 (propofol) | Drug | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
|
Blood concentration of ICI35,868 (propofol) |
| At the end of the initiation period and every 2 minutes during the maintenance period |
| Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5. | Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7) |
| Moriya |
| Ibaragi |
| Japan |
| FG002 | Arm 3 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute |
| FG003 | Arm 4 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute |
| FG004 | Arm 5 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute |
| FG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
| FG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
| Administered Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Placebo | Infusion of placebo, same infusion rates as for arm 2 |
| BG001 | Arm 2 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute |
| BG002 | Arm 3 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute |
| BG003 | Arm 4 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute |
| BG004 | Arm 5 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute |
| BG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
| BG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Procedures | Patients underwent either esophagogastroduodenoscopy (EGD) or colonoscopy. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 2 Minutes From Beginning of Maintenance Period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5. | Posted | Number | Participants | 2 minutes from the beginning of the maintenance period |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Modified Observers Assessment of Alertness/Sedation (MOAA/S) Score 4 Minutes From Beginning of Maintenance Period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5. | Posted | Number | Participants | 4 minutes from the beginning of the maintenance period |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Satisfaction With Sedation Instrument (PSSI) Questionnaire | The PSSI is a 100-point visual analog scale measuring a patient's satisfaction with sedation. Scores range from 0 (Very dissatisfied) to 100 (Very satisfied). | Posted | Mean | Standard Deviation | Units on a scale | 24 - 48 hours after completion of the procedure |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Blood Concentrations of Propofol | Blood concentration of ICI35,868 (propofol) | Posted | Mean | Standard Deviation | µg/mL | At the end of the initiation period and every 2 minutes during the maintenance period |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Modified Observers Assessment of Alertness/Sedation (MOAA/S) at End of Initiation Period | The MOAA/S is a 6-point ordinal scale measuring a patient's level of sedation. Scores range from 0 (No response to painful stimulus [trapezius squeeze]) to 5 (Responds readily to name spoken in normal tone [awake]). MOAA/S scores were classified as 0-1, 2-4 and 5. | Posted | Number | Participants | Last measurement in maintenance period (3 minutes for arms 1-5; 1 minute for arm 6, 5 minute for arm 7) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - Placebo | Infusion of placebo, same infusion rates as for arm 2 | 0 | 20 | 5 | 20 | ||
| EG001 | Arm 2 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute | 0 | 20 | 0 | 20 | ||
| EG002 | Arm 3 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute | 0 | 20 | 0 | 20 | ||
| EG003 | Arm 4 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute | 0 | 20 | 1 | 20 | ||
| EG004 | Arm 5 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute | 0 | 20 | 6 | 20 | ||
| EG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute | 0 | 10 | 1 | 10 | ||
| EG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute | 0 | 10 | 2 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Extrasystoles | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood Pressure Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Heart Rate Increased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
If the PI wants to publish the results, the PI must send the English documents to AZ beforehand. And AZ can review and revise the documents, after that, AZ will give the approval to the PI about the publication of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | Astrazeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Colonoscopy |
|
| MOAA/S Score 2-4 |
|
| MOAA/S Score 5 |
|
| OG004 | Arm 5 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute |
| OG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
| OG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
|
|
| Arm 5 - ICI35,868 (Propofol) |
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute |
| OG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
| OG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
|
|
Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
| OG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
| OG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
|
|
| OG004 | Arm 5 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute |
| OG005 | Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute |
| OG006 | Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute |
|
|