Healthy VolunteersPhase 1NCT01355588

Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers

A Phase 1 study testing Ketorolac Tromethamine, Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) and Ketorolac Tromethamine with 5% Lidocaine HCl in people with Healthy Volunteers, run by Egalet Ltd at 1 site in United Kingdom.

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

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Ketorolac Tromethamine, Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) and Ketorolac Tromethamine with 5% Lidocaine HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2005to Mar 2006
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 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female volunteers, aged 18 to 60 years inclusive
Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding
All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilisation) throughout the study period
Subject had given signed informed consent
Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)
Subject's medical history was considered normal, with no clinically significant abnormalities

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Subject was considered to be in good health in the opinion of the Investigator as determined by a pre-study physical examination with no clinically significant abnormalities, vital signs within normal range and an ECG with no clinically significant abnormalities
Subject's pre-study clinical laboratory findings were within normal range or, if outside of the normal range, not deemed clinically significant in the opinion of the Investigator
Subject had bilateral patent nasal airways at screening as assessed by the Investigator
Body weight was at least 70 kg

Who cannot join

Subject had a clinically significant illness in the 4 weeks before screening
Use of prescribed medications in the 3 weeks prior to dosing or over-the-counter preparations for 7 days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted
Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening
Subject had history of alcohol abuse or drank in excess of 28 units per week (males) or 21 units per week (females)
Current tobacco use or a history of smoking within the past 5 years
Subject was, in the opinion of the Investigator, not suitable to participate in the study

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Subjects who had participated in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
Subjects who had a positive result of HIV screen, Hepatitis B screen or Hepatitis C screen
Subjects with a serious adverse reaction or significant hypersensitivity to any drug
Subjects who has donated 500 mL or more of blood within the 3 months prior to screening
Any 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 have interfered with the absorption of the nasal spray or with the assessment of AEs
Any suspicion of rhinitis medicamentosa (chronic daily use of topical decongestants)
Use of a monoamine oxidase inhibitor in the 14 days prior to study entry
Active peptic ulcer disease, gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
Anemia due to unexplained or known gastrointestinal bleeding
History of asthma or any other chronic pulmonary disorder
Renal impairment or a risk of renal failure due to volume depletion
Known sensitivity to lidocaine hydrochloride

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Medeval Ltd
Manchester

Other trials in United Kingdom

About this study

Official title: A Phase 1, Double-blind, 4-way Crossover Study of the Tolerability, Safety and Pharmacokinetics of 4 Formulations of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers

This was a phase 1, double-blind, 4-way crossover study in healthy male and female volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg. There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects were randomised to receive either a single intranasal dose of 30 mg ketorolac tromethamine alone or single intranasal dose of 30 mg ketorolac tromethamine with 4%, 5% or 6% lidocaine hydrochloride. At the end of the study each subject had received all 4 treatments.

The primary objective of this study in healthy volunteers was to compare the safety, tolerability, and pharmacokinetics of 4 formulations of ketorolac tromethamine. A secondary objective was to monitor lidocaine hydrochloride plasma levels.

Conditions: Healthy Volunteers
Being tested: Ketorolac Tromethamine, Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl), Ketorolac Tromethamine with 5% Lidocaine HCl, 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl

What participants receive

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

Ketorolac TromethamineDrug
30 mg Ketorolac Tromethamine intranasal (IN)
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)Drug
30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
Ketorolac Tromethamine with 5% Lidocaine HClDrug
30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
30 mg Ketorolac Tromethamine with 6% Lidocaine HClDrug
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN

Study groups in NCT01355588
Study group	Role	What they receive
Ketorolac Tromethamine	Experimental	Not described Receives: Drug: Ketorolac Tromethamine
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)	Experimental	Not described Receives: Drug: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)
Ketorolac Tromethamine with 5% Lidocaine HCl	Experimental	Not described Receives: Drug: Ketorolac Tromethamine with 5% Lidocaine HCl
Ketorolac Tromethamine with 6% Lidocaine HCl	Experimental	Not described Receives: Drug: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl

What is being measured

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

Maximum Observed Plasma Concentration (Cmax)
Measured: 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
Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)
Measured: 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
Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)
Measured: 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

Secondary outcomes (1)

Time to Reach Maximum Plasma Concentration (Tmax)
Measured: 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

Timeline

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

Aug 2005Mar 2006

First posted18 May 2011 (estimated)
Study startAug 2005
Primary completionSep 2005
Study completionMar 2006

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.
Other trials for Healthy VolunteersStudies 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: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01355588
Sponsor's protocol ID: ROX 2005-02
Status last verified: Feb 2017
First submitted: 16 May 2011
Last updated: 16 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Double-blind, 4-way Crossover Study of the Tolerability, Safety and Pharmacokinetics of 4 Formulations of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers
ClinicalTrials.gov ID: NCT01355588
Acronym / sponsor ID: ROX 2005-02
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Egalet LtdIndustry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Sep 2005 (actual)
Study completion: Mar 2006 (actual)
First posted: 18 May 2011 (estimated)
Results: Posted 3 May 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: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Ketorolac Tromethamine	Experimental	Drug: Ketorolac Tromethamine
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)	Experimental	Drug: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)
Ketorolac Tromethamine with 5% Lidocaine HCl	Experimental	Drug: Ketorolac Tromethamine with 5% Lidocaine HCl
Ketorolac Tromethamine with 6% Lidocaine HCl	Experimental	Drug: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Male or female volunteers, aged 18 to 60 years inclusive
Female subjects of child bearing potential must have had a negative urine pregnancy test prior to entry into the study and must not have been breast feeding
All female subjects of child bearing potential and all male subjects with female partners of child bearing potential must have consented to use a medically acceptable method of contraception (oral or implanted contraceptive hormones, condom or diaphragm with spermicidal agent, intrauterine device or surgical sterilisation) throughout the study period
Subject had given signed informed consent
Subject was within 20% of normal weight for his/her height and body build according to the table of "Desirable Weights for Men and Women" (Metropolitan Life Insurance Co. 1999)

Key exclusion criteria (20 listed)

Subject had a clinically significant illness in the 4 weeks before screening
Use of prescribed medications in the 3 weeks prior to dosing or over-the-counter preparations for 7 days prior to dosing, except paracetamol which was allowed up to 48 hours prior to dosing. However, use of multivitamins and oral contraceptives were permitted
Subject had a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening
Subject had history of alcohol abuse or drank in excess of 28 units per week (males) or 21 units per week (females)
Current tobacco use or a history of smoking within the past 5 years

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 Tromethamine30 mg Ketorolac Tromethamine intranasal (IN)	Drug	Ketorolac Tromethamine
Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN	Drug	Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)
Ketorolac Tromethamine with 5% Lidocaine HCl30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN	Drug	Ketorolac Tromethamine with 5% Lidocaine HCl
30 mg Ketorolac Tromethamine with 6% Lidocaine HCl30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN	Drug	Ketorolac Tromethamine with 6% Lidocaine HCl

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: 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
Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)
Time frame: 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
Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)
Time frame: 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

1 secondary outcome

Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 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 and safety

Results posted to the registry on 3 May 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
Treatment A, Treatment C, Treatment D, Treatment B	4	4
Treatment B, Treatment D, Treatment C, Treatment A	4	4
Treatment C, Treatment B, Treatment A, Treatment D	4	4
Treatment D, Treatment A, Treatment B, Treatment C	4	4

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

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

Measure	Ketorolac Tromethamine n = 16	Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl) n = 16	Ketorolac Tromethamine With 5% Lidocaine HCl n = 16	Ketorolac Tromethamine With 6% Lidocaine HCl n = 16
Value	2059.6 (801.7)	1963.1 (1020.8)	1799.9 (714.1)	2048.5 (817.6)

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)

Measure	Ketorolac Tromethamine n = 16	Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl) n = 16	Ketorolac Tromethamine With 5% Lidocaine HCl n = 16	Ketorolac Tromethamine With 6% Lidocaine HCl n = 16
Value	8440.6 (4021.2)	7856.0 (4211.8)	7561.5 (4051.2)	8103.8 (3786.3)

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

Measure	Ketorolac Tromethamine n = 16	Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl) n = 16	Ketorolac Tromethamine With 5% Lidocaine HCl n = 16	Ketorolac Tromethamine With 6% Lidocaine HCl n = 16
Value	9061.9 (4526.8)	8694.5 (4477.1)	8086.8 (4608.2)	8677.6 (4301.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 month and 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketorolac Tromethamine	0 of 16 (0%)	11 of 16 (68.8%)	Not reported
Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
Ketorolac Tromethamine With 5% Lidocaine HCl	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
Ketorolac Tromethamine With 6% Lidocaine HCl	0 of 16 (0%)	8 of 16 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Cyril Clarke, BSc MB BS MFPM principal investigator

Medeval Limited

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

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 20 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 16 Mar 2017. 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 Kingdom. 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 3 May 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?

Maximum Observed Plasma Concentration (Cmax) (time frame: 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). The study lists 3 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 NCT01355588.

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 16 Mar 2017.