Trial Outcomes & Findings for Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers (NCT NCT01355588)
NCT ID: NCT01355588
Last Updated: 2017-03-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose
Results posted on
2017-03-16
Participant Flow
1 month and 2 weeks; Medeval Limited Skelton House, Manchester Science Park, Lloyd Street North, Manchester M15 6SH, U.K.
Participant milestones
| Measure |
Treatment A, Treatment C, Treatment D, Treatment B
Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Treatment B, Treatment D, Treatment C, Treatment A
Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Treatment C, Treatment B, Treatment A, Treatment D
Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
Treatment D, Treatment A, Treatment B, Treatment C
Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
|---|---|---|---|---|
|
First Intervention (Day 1)
STARTED
|
4
|
4
|
4
|
4
|
|
First Intervention (Day 1)
COMPLETED
|
4
|
4
|
4
|
4
|
|
First Intervention (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (3-7 Days)
STARTED
|
4
|
4
|
4
|
4
|
|
Washout (3-7 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Washout (3-7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (After Washout)
STARTED
|
4
|
4
|
4
|
4
|
|
Second Intervention (After Washout)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Second Intervention (After Washout)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention (After Washout)
STARTED
|
4
|
4
|
4
|
4
|
|
Third Intervention (After Washout)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Third Intervention (After Washout)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Fourth Intervention (After Washout)
STARTED
|
4
|
4
|
4
|
4
|
|
Fourth Intervention (After Washout)
COMPLETED
|
4
|
4
|
4
|
4
|
|
Fourth Intervention (After Washout)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Treatment A, Treatment C, Treatment D, Treatment B
n=4 Participants
Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Treatment B, Treatment D, Treatment C, Treatment A
n=4 Participants
Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Treatment C, Treatment B, Treatment A, Treatment D
n=4 Participants
Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
Treatment D, Treatment A, Treatment B, Treatment C
n=4 Participants
Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
Total
n=16 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
34.25 years
STANDARD_DEVIATION 17.21 • n=5 Participants
|
40.75 years
STANDARD_DEVIATION 19.97 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 15.90 • n=5 Participants
|
50.25 years
STANDARD_DEVIATION 10.31 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 16.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-doseOutcome measures
| Measure |
Ketorolac Tromethamine
n=16 Participants
Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)
n=16 Participants
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Ketorolac Tromethamine With 5% Lidocaine HCl
n=16 Participants
Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
Ketorolac Tromethamine With 6% Lidocaine HCl
n=16 Participants
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
2059.6 ng/mL
Standard Deviation 801.7
|
1963.1 ng/mL
Standard Deviation 1020.8
|
1799.9 ng/mL
Standard Deviation 714.1
|
2048.5 ng/mL
Standard Deviation 817.6
|
PRIMARY outcome
Timeframe: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-doseOutcome measures
| Measure |
Ketorolac Tromethamine
n=16 Participants
Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)
n=16 Participants
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Ketorolac Tromethamine With 5% Lidocaine HCl
n=16 Participants
Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
Ketorolac Tromethamine With 6% Lidocaine HCl
n=16 Participants
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)
|
8440.6 ng*h/mL
Standard Deviation 4021.2
|
7856.0 ng*h/mL
Standard Deviation 4211.8
|
7561.5 ng*h/mL
Standard Deviation 4051.2
|
8103.8 ng*h/mL
Standard Deviation 3786.3
|
PRIMARY outcome
Timeframe: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-doseOutcome measures
| Measure |
Ketorolac Tromethamine
n=16 Participants
Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)
n=16 Participants
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Ketorolac Tromethamine With 5% Lidocaine HCl
n=16 Participants
Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
Ketorolac Tromethamine With 6% Lidocaine HCl
n=16 Participants
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)
|
9061.9 ng*h/mL
Standard Deviation 4526.8
|
8694.5 ng*h/mL
Standard Deviation 4477.1
|
8086.8 ng*h/mL
Standard Deviation 4608.2
|
8677.6 ng*h/mL
Standard Deviation 4301.0
|
SECONDARY outcome
Timeframe: Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-doseOutcome measures
| Measure |
Ketorolac Tromethamine
n=16 Participants
Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)
n=16 Participants
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Ketorolac Tromethamine With 5% Lidocaine HCl
n=16 Participants
Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
Ketorolac Tromethamine With 6% Lidocaine HCl
n=16 Participants
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
0.510 hours
Interval 0.5 to 1.5
|
0.500 hours
Interval 0.25 to 4.0
|
0.390 hours
Interval 0.25 to 0.75
|
0.410 hours
Interval 0.25 to 0.5
|
Adverse Events
Ketorolac Tromethamine
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ketorolac Tromethamine With 5% Lidocaine HCl
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ketorolac Tromethamine With 6% Lidocaine HCl
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketorolac Tromethamine
n=16 participants at risk
Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
|
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)
n=16 participants at risk
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
|
Ketorolac Tromethamine With 5% Lidocaine HCl
n=16 participants at risk
Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
|
Ketorolac Tromethamine With 6% Lidocaine HCl
n=16 participants at risk
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Vascular disorders
Hematoma
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Vascular disorders
Hot flush
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
56.2%
9/16 • 1 month and 2 weeks
|
18.8%
3/16 • 1 month and 2 weeks
|
37.5%
6/16 • 1 month and 2 weeks
|
18.8%
3/16 • 1 month and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
6.2%
1/16 • 1 month and 2 weeks
|
12.5%
2/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
General disorders
Fatigue
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Psychiatric disorders
Nervousness
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
0.00%
0/16 • 1 month and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
2/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
6.2%
1/16 • 1 month and 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
37.5%
6/16 • 1 month and 2 weeks
|
37.5%
6/16 • 1 month and 2 weeks
|
37.5%
6/16 • 1 month and 2 weeks
|
37.5%
6/16 • 1 month and 2 weeks
|
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