Trial Outcomes & Findings for Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects (NCT NCT01365624)
NCT ID: NCT01365624
Last Updated: 2013-02-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose
Results posted on
2013-02-06
Participant Flow
February 2008 through April 2008; Clinical Unit
After subjects had given their informed consent, subjects were required to pass a screening visit within 3 weeks prior to study drug administration.
Participant milestones
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
Baseline characteristics by cohort
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age Continuous
|
71.9 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-doseOutcome measures
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
Cmax (Maximum Plasma Concentration)
|
1782.286 ng/mL
Standard Deviation 1184.843
|
1840.111 ng/mL
Standard Deviation 995.930
|
PRIMARY outcome
Timeframe: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-doseOutcome measures
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
Tmax (Time to Reach Maximum Plasma Concentration)
|
0.750 hours
Interval 0.5 to 1.0
|
0.750 hours
Interval 0.25 to 1.0
|
PRIMARY outcome
Timeframe: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-doseOutcome measures
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose
|
7323.5 ng*hours/mL
Standard Deviation 4633.1
|
6536.5 ng*hours/mL
Standard Deviation 3361.8
|
PRIMARY outcome
Timeframe: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dosePopulation: Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.
Outcome measures
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=13 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity
|
8794.8 ng*hours/mL
Standard Deviation 4129.4
|
6890.8 ng*hours/mL
Standard Deviation 3448.5
|
PRIMARY outcome
Timeframe: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dosePopulation: Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.
Outcome measures
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=13 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
t1/2z (Terminal Half-life)
|
4.521 hours
Standard Deviation 1.142
|
3.313 hours
Standard Deviation 0.961
|
PRIMARY outcome
Timeframe: Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dosePopulation: Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.
Outcome measures
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=13 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 Participants
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
MRT (Mean Residence Time)
|
6.024 hours
Standard Deviation 1.496
|
4.441 hours
Standard Deviation 1.060
|
Adverse Events
Ketorolac Tromethamine (Elderly Adults ≥ 65)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ketorolac Tromethamine (Nonelderly Adults < 65)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketorolac Tromethamine (Elderly Adults ≥ 65)
n=15 participants at risk
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
Ketorolac Tromethamine (Nonelderly Adults < 65)
n=15 participants at risk
Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
|
|---|---|---|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • Number of events 1 • 1 month and 1 week
|
0.00%
0/15 • 1 month and 1 week
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • 1 month and 1 week
|
6.7%
1/15 • Number of events 1 • 1 month and 1 week
|
Additional Information
David Bregman, M.D., Ph.D
Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place