Healthy SubjectsPhase 1NCT01356212
Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device
A Phase 1 study testing Ketorolac tromethamine in people with Healthy Subjects, run by Egalet Ltd at 1 site in United Kingdom.
Trial summary
This was a randomised three-way crossover design study. The study consisted of three study periods each separated by a minimum 44 hour washout period. During the course of each study period, scintigraphic images were acquired at planned intervals after dosing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy 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
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2002to Dec 2002
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating, surgically sterile or post-menopausal females (post-menopausal was defined as > 2 years post-last period and more than 50 years of age), or using an acceptable form of contraception as defined in section 9.3.2 (g)
- Aged 18-65 years
- Body Mass Index of between 18 and 30 kg/m2
Who cannot join
- Participation in a clinical research study involving investigational drugs or dosage forms within the previous 4 months
- Subjects who had sought advice from their GP or consulted a counsellor for abuse or misuse of alcohol, non-medical, medicinal drugs, or other substance-abuse such as solvents. Any current or past use of Class A drugs such as opiates, ecstasy, LSD, and amphetamines (Class B). Volunteers that admitted to past use of cannabis were not excluded as long as they had a negative drugs of abuse test and had been abstinent for at least 12 months
- Positive drugs of abuse test result
- Regular alcohol consumption in males >21 units per week and females >14 units per week. (one unit of alcohol was defined as 0.5 pint (280 ml) of beer or cider, 1 glass (125 ml) wine, 1 glass (70 ml) of sherry or port, 1 measure (25 ml) of whisky, brandy or rum. For low alcohol drinks, one unit of alcohol was defined as 2 glasses (250 ml) of low alcohol wine and 5 half pints (840 ml) of low alcohol beer)
- Current smokers, i.e. those who had smoked within the last 12 months
- A breath carbon monoxide reading of greater than 10 ppm either at the pre-study medical examination or on a study day prior to dosing
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- Females of child bearing potential who were sexually active and either not surgically sterile, post-menopausal or not using a form of acceptable contraceptive (contraceptive pills/injection, condoms with spermicide, IUCDs (coils) and diaphragms with spermicide (only if the woman was 35 or more) or abstinence
- Radiation exposure from clinical trials, including that from the present study and from diagnostic X-rays but excluding background radiation, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No subject whose occupational exposure is monitored will participate in the study
- Clinically significant abnormal biochemistry, haematology or urinalysis
- Screening FEV1 < 80% of the predicted value for their age, sex, height and race
- History of chronic respiratory disorders or bronchospasm
- History of adverse reaction or allergy to ketorolac or di-sodium EDTA
- History of severe or multiple allergies, including hayfever and perennial rhinitis
- History of adverse reaction or allergy to aspirin or any other non-steroidal anti inflammatory drug (e.g., ibuprofen, flurbiprofen, ketoprofen or diclofenac)
- History of infantile bronchiolitis, or a history or the presence of asthma, or wheezy respiration, hayfever and perennial rhinitis
- History of nasal fracture, nasal deformity or nasal polyps
- History of disease, surgery, or abnormality of the upper respiratory tract, especially the nasal cavity
- History of significant nose bleeds
- Sinusitis within four weeks of the first study period
- Nasal jewelry or nasal piercings
- Subjects using topical nasal medication e.g. decongestants, within 14 days prior to the first dosing day
- Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the previous 3 months
- Subjects taking any medication that might affect the respiratory tract within 14 days of the first study day
- Non-prescription and prescription medication (including vitamins and natural or herbal remedies eg. St Johns Wort) within 14 days of the first study day (oral contraceptives, contraceptive implants or depot injections, intra-uterine devices with hormonal implants, Hormone Replacement Therapy (HRT) and occasional paracetamol (up to 4 g daily) were permitted)
- History of peptic ulceration or gastrointestinal bleeding
- History of kidney disease
- History of clotting disorders
- Failure to satisfy the Principal Medical Investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Pharmaceutical Profiles, Ltd
Ruddington, Nottingham, NG11 6JS
About this study
Official title: Scintigraphic Assessment of Nasal Deposition and Clearance of 99mTc DTPA Ketorolac Solution Administered Using the Valois Nasal Spray Device
This was a randomised three-way crossover design study. The study consisted of three study periods each separated by a minimum 44 hour washout period. During the course of each study period, scintigraphic images were acquired at planned intervals after dosing. Subjects were able to leave the clinical unit after the completion of study specific procedures at 6 hours post-dose.
The primary objective of the study was to determine whether any of the radiolabelled ketorolac formulation was deposited in the lungs of healthy volunteers following nasal inhalation under three different conditions (gentle sniff-inhalation with subject standing, vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject semi-supine). The secondary objectives were to determine the deposition pattern of radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a six-hour period.
- 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
30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
Ketorolac tromethamineDrug
30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
Ketorolac tromethamineDrug
30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| Regimen A: Ketorolac tromethamine (Gentle Sniff - Upright) | Experimental | Gentle sniff-inhalation with the volunteer upright for dosing and imaging Receives: Drug: Ketorolac tromethamine |
| Regimen B: Ketorolac tromethamine (Vigorous Sniff - Upright) | Experimental | Vigorous sniff-inhalation with the volunteer upright for dosing and imaging Receives: Drug: Ketorolac tromethamine |
| Regimen C: Ketorolac tromethamine (Gentle Sniff - Semi-supine) | Experimental | Gentle sniff-inhalation with the volunteer semi-supine for dosing and imaging Receives: Drug: Ketorolac tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scintigraphic images of radiolabeled ketorolac solution entering the lungs and subsequently being cleared from the lungs following administration to the nostrils using a Valois nasal device.
Measured: Change from baseline to immediately post-dose, 10, 20, 30, 45, and 60 minutes and 2, 4, and 6 hours post dose
Secondary outcomes (1)
Scintigraphic assessment of the deposition pattern of radiolabeled ketorolac solution in the nasal cavity, nasopharynx, esophagus, and stomach.
Measured: Change from baseline to immediately post-dose, 10, 20, 30, 45, and 60 minutes and 2, 4, and 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startSep 2002
- Primary completionOct 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- L Rankin, MD, Principal investigator, Pharmaceutical Profiles, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01356212
- Sponsor's protocol ID
- ROX 2002-02
- Status last verified
- Feb 2017
- First submitted
- 16 May 2011
- Last updated
- 8 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scintigraphic Assessment of Nasal Deposition and Clearance of 99mTc DTPA Ketorolac Solution Administered Using the Valois Nasal Spray Device
- ClinicalTrials.gov ID
- NCT01356212
- Acronym / sponsor ID
- ROX 2002-02
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomised three-way crossover design study. The study consisted of three study periods each separated by a minimum 44 hour washout period. During the course of each study period, scintigraphic images were acquired at planned intervals after dosing. Subjects were able to leave the clinical unit after the completion of study specific procedures at 6 hours post-dose.
The primary objective of the study was to determine whether any of the radiolabelled ketorolac formulation was deposited in the lungs of healthy volunteers following nasal inhalation under three different conditions (gentle sniff-inhalation with subject standing, vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject semi-supine). The secondary objectives were to determine the deposition pattern of radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a six-hour period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen A: Ketorolac tromethamine (Gentle Sniff - Upright) | Experimental | Drug: Ketorolac tromethamineGentle sniff-inhalation with the volunteer upright for dosing and imaging |
| Regimen B: Ketorolac tromethamine (Vigorous Sniff - Upright) | Experimental | Drug: Ketorolac tromethamineVigorous sniff-inhalation with the volunteer upright for dosing and imaging |
| Regimen C: Ketorolac tromethamine (Gentle Sniff - Semi-supine) | Experimental | Drug: Ketorolac tromethamineGentle sniff-inhalation with the volunteer semi-supine for dosing and imaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or non-pregnant, non-lactating, surgically sterile or post-menopausal females (post-menopausal was defined as > 2 years post-last period and more than 50 years of age), or using an acceptable form of contraception as defined in section 9.3.2 (g)
- Aged 18-65 years
- Body Mass Index of between 18 and 30 kg/m2
Key exclusion criteria (28 listed)
- Participation in a clinical research study involving investigational drugs or dosage forms within the previous 4 months
- Subjects who had sought advice from their GP or consulted a counsellor for abuse or misuse of alcohol, non-medical, medicinal drugs, or other substance-abuse such as solvents. Any current or past use of Class A drugs such as opiates, ecstasy, LSD, and amphetamines (Class B). Volunteers that admitted to past use of cannabis were not excluded as long as they had a negative drugs of abuse test and had been abstinent for at least 12 months
- Positive drugs of abuse test result
- Regular alcohol consumption in males >21 units per week and females >14 units per week. (one unit of alcohol was defined as 0.5 pint (280 ml) of beer or cider, 1 glass (125 ml) wine, 1 glass (70 ml) of sherry or port, 1 measure (25 ml) of whisky, brandy or rum. For low alcohol drinks, one unit of alcohol was defined as 2 glasses (250 ml) of low alcohol wine and 5 half pints (840 ml) of low alcohol beer)
- Current smokers, i.e. those who had smoked within the last 12 months
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 (15 mg (100 ul) per nostril) administered intranasally | Drug | Regimen A: Ketorolac tromethamine (Gentle Sniff - Upright) |
| Ketorolac tromethamine30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally | Drug | Regimen B: Ketorolac tromethamine (Vigorous Sniff - Upright) |
| Ketorolac tromethamine30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally | Drug | Regimen C: Ketorolac tromethamine (Gentle Sniff - Semi-supine) |
Primary outcome
Scintigraphic images of radiolabeled ketorolac solution entering the lungs and subsequently being cleared from the lungs following administration to the nostrils using a Valois nasal device.
Time frame: Change from baseline to immediately post-dose, 10, 20, 30, 45, and 60 minutes and 2, 4, and 6 hours post dose
1 secondary outcome
Scintigraphic assessment of the deposition pattern of radiolabeled ketorolac solution in the nasal cavity, nasopharynx, esophagus, and stomach.
Time frame: Change from baseline to immediately post-dose, 10, 20, 30, 45, and 60 minutes and 2, 4, and 6 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
L Rankin, MD principal investigator
Pharmaceutical Profiles, Ltd
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 Egalet Ltd at 1 site in United Kingdom.
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 3 inclusion and 28 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 8 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Scintigraphic images of radiolabeled ketorolac solution entering the lungs and subsequently being cleared from the lungs following administration to the nostrils using a Valois nasal device. (time frame: Change from baseline to immediately post-dose, 10, 20, 30, 45, and 60 minutes and 2, 4, and 6 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2017.