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The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age >/= 65 years, and/or weight < 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight >/= 55 kg and weight < 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fospropofol disodium Subgroup 1 Lower Dose | Active Comparator |
| |
| : fospropofol disodium Subgroup 1 Approved Dose | Active Comparator |
| |
| fospropofol disodium Subgroup 2 Lower Dose | Active Comparator |
| |
| fospropofol disodium Subgroup 2 Approved Dose | Active Comparator |
| |
| fospropofol disodium Subgroup 3 Lower Dose | Active Comparator |
| |
| fospropofol disodium Subgroup 3 Approved Dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fospropofol disodium Subgroup 1 Lower Dose | Drug | Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sedation Success | Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Success | Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. | Day 1 |
| Number of Participants With Modified Sedation Success |
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Subjects who meet all of the following criteria will be included in the study:
Male and female adult candidates for diagnostic or therapeutic colonoscopy with at least one of the following characteristics:
Females of childbearing potential must have a negative beta human chorionic gonadotropin (?hCG) urine pregnancy test at Visit 1 (Screening) and prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device [IUD], or have a vasectomised partner) having starting for at least 1 menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential;
Are willing and able to comply with all aspects of the protocol; and
Provide written informed consent.
Subjects who meet any of the following criteria will be excluded from participation in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Ferry | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Southern California Permanente Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Subgroup 1, Lower Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. The doses were weight-adjusted for each subject, with 6.5mg of Lusedra per kg during the Randomization Phase (1 day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| fospropofol disodium Subgroup 1 Approved Dose | Drug | (Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II) |
|
| fospropofol disodium Subgroup 2 Lower Dose | Drug | Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight < 60 kg and Age >/=65 years and ASA 3 or 4 |
|
| fospropofol disodium Subgroup 2 Approved Dose | Drug | (Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4 |
|
| fospropofol disodium Subgroup 3 Lower Dose | Drug | (Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4 |
|
| fospropofol disodium Subgroup 3 Approved Dose | Drug | Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4 |
|
Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness. |
| Day 1 |
| Baldwin Park |
| California |
| 91706 |
| United States |
| Desta Digestive Disease Medical Center | San Diego | California | 92114 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Center for Advanced Gastroenterology | Maitland | Florida | 32751 | United States |
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| Miami Research Associates | South Miami | Florida | 33143 | United States |
| Sheridan Clinical Research | Sunrise | Florida | 33323 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Research Associates of New York, LLP | New York | New York | 10075 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Ohio State University Medical Center Department of Anesthesiology | Columbus | Ohio | 43210 | United States |
| Ilumina Clinical Associates, Keystone Headache and Pain Mgt Center, Tyrone Hospital | Tyrone | Pennsylvania | 16686 | United States |
| Ilumina Clinical Associates | Uniontown | Pennsylvania | 15401 | United States |
| Digestive Health Associates | Plano | Texas | 75075 | United States |
| Clinical Trial Network | Spring | Texas | 77386 | United States |
| Utah Digestive Health Institute | Clinton | Utah | 84015 | United States |
| Northern Utah Gastroenterology | Logan | Utah | 84341-2534 | United States |
| Advance Clinical Research | Odgen | Utah | 84405 | United States |
| Utah Clinical Trials, LLC | Salt Lake City | Utah | 84107 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | United States |
| FG001 |
| Subgroup 1, Approved Dose |
This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomization Phase (1 day). |
| FG002 | Subgroup 2, Lower Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day). |
| FG003 | Subgroup 2, Approved Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomization Phase (1 day). |
| FG004 | Subgroup 3, Lower Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 3.9mg of Lusedra per kg during the Randomization Phase (1 day). |
| FG005 | Subgroup 3, Approved Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subgroup 1, Lower Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| BG001 | Subgroup 1, Approved Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day). |
| BG002 | Subgroup 2, Lower Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| BG003 | Subgroup 2, Approved Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day). |
| BG004 | Subgroup 3, Lower Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| BG005 | Subgroup 3, Approved Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Safety Analysis Set. | Number | Participants |
| |||||||||||||||
| Sex: Female, Male | Safety Analysis Set: All subjects who received atleast one dose of study medication and had atleast one postdose safety assessment. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Safety Analysis Set. | Number | Participants |
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| 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 | Number of Participants With Sedation Success | Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation. | Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement. | Posted | Number | Participants | Day 1 |
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| Secondary | Number of Participants With Treatment Success | Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. | Full Analysis Population. | Posted | Number | Participants | Day 1 |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Modified Sedation Success | Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score <2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness. | Full Analysis Population. | Posted | Number | Participants | Day 1 |
|
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The AE/SAE information reflects the Safety Population for the intended randomization and does not redistribute the one subject randomized to the lower dose group in error.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lower Dose | Includes subgroups 1-3 | 1 | 79 | 23 | 79 | ||
| EG001 | Approved Dose | Includes subgroups 1-3 | 2 | 74 | 15 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.1 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA v13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulum | Gastrointestinal disorders | MedDRA v13.1 | Systematic Assessment |
| |
| Polyp | General disorders | MedDRA v13.1 | Systematic Assessment |
| |
| Burning Sensation | Nervous system disorders | MedDRA v13.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v13.1 | Systematic Assessment |
| |
| Pruritus Genital | Reproductive system and breast disorders | MedDRA v13.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| >=65 Years |
|
| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Other |
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| OG003 | Subgroup 2, Approved Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day). |
| OG004 | Subgroup 3, Lower Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| OG005 | Subgroup 3, Approved Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
|
|
| OG002 |
| Subgroup 2, Lower Dose |
This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| OG003 | Subgroup 2, Approved Dose | This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day). |
| OG004 | Subgroup 3, Lower Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
| OG005 | Subgroup 3, Approved Dose | This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day). |
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