Healthy SubjectsPhase 1NCT01365624

Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

A Phase 1 study testing Ketorolac tromethamine in people with Healthy Subjects, run by American Regent, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Ketorolac tromethamine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Jul 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The elderly population consisted of male or female volunteers aged > of = 65 years
The nonelderly adult population consisted of male or female volunteers aged < 65 years
Generally good health in the opinion of the Investigator, as determined by a prestudy physical examination with no clinically significant abnormalities for age, vital signs within normal ranges or outside normal range but not deemed clinically significant for age in the opinion of the Investigator, and no clinically significant electrocardiogram (ECG) abnormalities for age
Bilaterally patent nasal airways at screening as assessed by the Investigator
Body mass index (BMI) 15-30 kg/m2
Female subjects of childbearing potential must consent to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device, or surgical sterilization) throughout the study period
Ability to provide written informed consent
Prestudy clinical laboratory findings within normal ranges or if outside normal range not deemed clinically significant for age in the opinion of the Investigator

Who cannot join

Allergy or sensitivity to ketorolac or formulation ingredients
History of co-existing nasal polyps, NSAID sensitivity, and asthma
Allergic reaction to aspirin or other NSAIDs
Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of AEs
Use of any prescribed or over-the-counter (OTC) drug in the 72 h prior to entry into the study with the exception of occasional acetaminophen up to 24 h prior to entry
Suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)

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Use of a monoamine oxidase (MAO) inhibitor in the 14 days prior to study entry
Positive serum test for human immunodeficiency virus (HIV) or hepatitis B or C
Positive alcohol breath test at screening or on entry into the study
Positive urine screen for any nonprescribed drug of abuse at screening or on entry into the study
History of cocaine use
Blood donation within 30 days of beginning study participation
Active peptic ulcer disease or a history of peptic ulcer disease or gastrointestinal bleeding
Serum creatinine > 2.0 mg/dL
Current tobacco use or a past history of smoking within 5 years of study entry
Any other clinically significant medical problem, which in the opinion of the Investigator would interfere with study participation
Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Seaview Research
Miami, Florida, 33126

Other trials in United States

About this study

Official title: A Phase 1 Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.

Conditions: Healthy Subjects
Being tested: Ketorolac tromethamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketorolac tromethamineDrug
Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)

Study groups in NCT01365624
Study group	Role	What they receive
Ketorolac tromethamine	Experimental	Not described Receives: Drug: Ketorolac tromethamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (Maximum Plasma Concentration)
Measured: 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
Tmax (Time to Reach Maximum Plasma Concentration)
Measured: 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
AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose
Measured: 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
AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity
Measured: 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
t1/2z (Terminal Half-life)
Measured: 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
MRT (Mean Residence Time)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Jul 2008

First posted3 Jun 2011 (estimated)
Study startFeb 2008
Primary completionApr 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01365624
Sponsor's protocol ID: ROX 2007-02
Status last verified: Jan 2013
First submitted: 1 Jun 2011
Last updated: 6 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bullingham R, Juan A. Comparison of intranasal ketorolac tromethamine pharmacokinetics in younger and older adults. Drugs Aging. 2012 Nov;29(11):899-904. doi: 10.1007/s40266-012-0023-2.
PubMed 23143939

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
ClinicalTrials.gov ID: NCT01365624
Acronym / sponsor ID: ROX 2007-02
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Apr 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 3 Jun 2011 (estimated)
Results: Posted 6 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ketorolac tromethamine	Experimental	Drug: Ketorolac tromethamine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

The elderly population consisted of male or female volunteers aged > of = 65 years
The nonelderly adult population consisted of male or female volunteers aged < 65 years
Generally good health in the opinion of the Investigator, as determined by a prestudy physical examination with no clinically significant abnormalities for age, vital signs within normal ranges or outside normal range but not deemed clinically significant for age in the opinion of the Investigator, and no clinically significant electrocardiogram (ECG) abnormalities for age
Bilaterally patent nasal airways at screening as assessed by the Investigator
Body mass index (BMI) 15-30 kg/m2

Key exclusion criteria (17 listed)

Allergy or sensitivity to ketorolac or formulation ingredients
History of co-existing nasal polyps, NSAID sensitivity, and asthma
Allergic reaction to aspirin or other NSAIDs
Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of AEs
Use of any prescribed or over-the-counter (OTC) drug in the 72 h prior to entry into the study with the exception of occasional acetaminophen up to 24 h prior to entry

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketorolac tromethamineSingle dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)	Drug	Ketorolac tromethamine

Primary outcome

Cmax (Maximum Plasma Concentration)
Time frame: 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
Tmax (Time to Reach Maximum Plasma Concentration)
Time frame: 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
AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose
Time frame: 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
AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity
Time frame: 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
t1/2z (Terminal Half-life)
Time frame: 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
MRT (Mean Residence Time)
Time frame: 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 and safety

Results posted to the registry on 6 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketorolac Tromethamine (Elderly Adults ≥ 65)	15	15
Ketorolac Tromethamine (Nonelderly Adults < 65)	15	15

Primary outcome: Cmax (Maximum Plasma Concentration)

Time frame: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Ketorolac Tromethamine (Elderly Adults ≥ 65) n = 15	Ketorolac Tromethamine (Nonelderly Adults < 65) n = 15
Value	1782.286 (1184.843)	1840.111 (995.930)

Primary outcome: Tmax (Time to Reach Maximum Plasma Concentration)

Measure	Ketorolac Tromethamine (Elderly Adults ≥ 65) n = 15	Ketorolac Tromethamine (Nonelderly Adults < 65) n = 15
Value	0.750 (0.50 to 1.00)	0.750 (0.25 to 1.00)

Primary outcome: AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose

Measure	Ketorolac Tromethamine (Elderly Adults ≥ 65) n = 15	Ketorolac Tromethamine (Nonelderly Adults < 65) n = 15
Value	7323.5 (4633.1)	6536.5 (3361.8)

Primary outcome: AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity

Measure	Ketorolac Tromethamine (Elderly Adults ≥ 65) n = 13	Ketorolac Tromethamine (Nonelderly Adults < 65) n = 15
Value	8794.8 (4129.4)	6890.8 (3448.5)

Population analysed: Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.

Adverse events

Time frame: 1 month and 1 week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketorolac Tromethamine (Elderly Adults ≥ 65)	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Ketorolac Tromethamine (Nonelderly Adults < 65)	0 of 15 (0%)	1 of 15 (6.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23143939Bullingham R, Juan A. Comparison of intranasal ketorolac tromethamine pharmacokinetics in younger and older adults. Drugs Aging. 2012 Nov;29(11):899-904. doi: 10.1007/s40266-012-0023-2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lincoln Bynum, MD study chair

ICON Developmental Solutions

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ketorolac tromethamine in people with Healthy Subjects, run by American Regent, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (Maximum Plasma Concentration) (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01365624, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.