Trial Outcomes & Findings for A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations (NCT NCT01127438)
NCT ID: NCT01127438
Last Updated: 2013-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
153 participants
Primary outcome timeframe
Day 1
Results posted on
2013-02-08
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
26
|
24
|
28
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
26
|
24
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose-ranging Study to Evaluate the Safety and Efficacy of LUSEDRA (Fospropofol Disodium) as an Intravenous Sedative for Diagnostic or Therapeutic Colonoscopy in Adult Special Populations
Baseline characteristics by cohort
| Measure |
Subgroup 1, Lower Dose
n=25 Participants
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).
|
Subgroup 1, Approved Dose
n=25 Participants
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).
|
Subgroup 2, Lower Dose
n=26 Participants
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).
|
Subgroup 2, Approved Dose
n=24 Participants
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).
|
Subgroup 3, Lower Dose
n=28 Participants
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).
|
Subgroup 3, Approved Dose
n=25 Participants
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).
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 Years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
77 Participants
n=8 Participants
|
|
Age, Customized
>=65 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
76 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
115 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
127 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Full Analysis Population: All treated subjects who received study drug and had at least one postdose efficacy measurement.
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.
Outcome measures
| Measure |
Subgroup 1, Lower Dose
n=25 Participants
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).
|
Subgroup 1, Approved Dose
n=25 Participants
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).
|
Subgroup 2, Lower Dose
n=25 Participants
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).
|
Subgroup 2, Approved Dose
n=25 Participants
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).
|
Subgroup 3, Lower Dose
n=28 Participants
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).
|
Subgroup 3, Approved Dose
n=25 Participants
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).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Sedation Success
|
18 Participants
|
24 Participants
|
18 Participants
|
21 Participants
|
19 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Full Analysis Population.
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.
Outcome measures
| Measure |
Subgroup 1, Lower Dose
n=25 Participants
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).
|
Subgroup 1, Approved Dose
n=25 Participants
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).
|
Subgroup 2, Lower Dose
n=25 Participants
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).
|
Subgroup 2, Approved Dose
n=25 Participants
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).
|
Subgroup 3, Lower Dose
n=28 Participants
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).
|
Subgroup 3, Approved Dose
n=25 Participants
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).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Success
|
18 Participants
|
24 Participants
|
18 Participants
|
21 Participants
|
19 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Full Analysis Population.
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.
Outcome measures
| Measure |
Subgroup 1, Lower Dose
n=25 Participants
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).
|
Subgroup 1, Approved Dose
n=25 Participants
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).
|
Subgroup 2, Lower Dose
n=25 Participants
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).
|
Subgroup 2, Approved Dose
n=25 Participants
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).
|
Subgroup 3, Lower Dose
n=28 Participants
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).
|
Subgroup 3, Approved Dose
n=25 Participants
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).
|
|---|---|---|---|---|---|---|
|
Number of Participants With Modified Sedation Success
|
16 Participants
|
20 Participants
|
18 Participants
|
18 Participants
|
17 Participants
|
20 Participants
|
Adverse Events
Lower Dose
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Approved Dose
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lower Dose
n=79 participants at risk
Includes subgroups 1-3
|
Approved Dose
n=74 participants at risk
Includes subgroups 1-3
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
1.3%
1/79
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.
|
0.00%
0/74
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/79
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.
|
1.4%
1/74
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.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/79
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.
|
1.4%
1/74
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.
|
Other adverse events
| Measure |
Lower Dose
n=79 participants at risk
Includes subgroups 1-3
|
Approved Dose
n=74 participants at risk
Includes subgroups 1-3
|
|---|---|---|
|
Gastrointestinal disorders
Diverticulum
|
10.1%
8/79
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.
|
2.7%
2/74
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.
|
|
General disorders
Polyp
|
6.3%
5/79
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.
|
2.7%
2/74
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.
|
|
Nervous system disorders
Burning Sensation
|
7.6%
6/79
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.
|
2.7%
2/74
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.
|
|
Nervous system disorders
Paraesthesia
|
6.3%
5/79
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.
|
5.4%
4/74
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.
|
|
Reproductive system and breast disorders
Pruritus Genital
|
5.1%
4/79
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.
|
10.8%
8/74
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.
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place