Trial · NCT01365611
Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects
NCT01365611, Phase 1, Completed, Egalet Ltd; results first posted 2013-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects. Trials, record NCT01365611. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01365611
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects
- NCT number
- NCT01365611
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Egalet Ltd
- Conditions
- Healthy Subjects
- Interventions
- Ketorolac tromethamine, Fluticasone Propionate
- First posted
- 2011-06-03
- Last updated
- 2017-03-15
- Results first posted
- 2013-04-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | |
| Primary | Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | |
| Primary | AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine). | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | |
| Primary | AUC Inf (the AUC From Time Zero to Infinity, Where Possible) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | |
| Primary | t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | |
| Primary | MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | ng/mL | MEAN | |
| PRIMARY | Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | hours | MEDIAN | |
| PRIMARY | AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine). | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | ng*hours/mL | MEAN | |
| PRIMARY | AUC Inf (the AUC From Time Zero to Infinity, Where Possible) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | The half-life could not be estimated for a subject due to the nature of the subject's PK profile. | ng*hours/mL | MEAN |
| PRIMARY | t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | The half-life could not be estimated for a subject due to the nature of the subject's PK profile. | hours | MEAN |
| PRIMARY | MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible) | PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6 | The half-life could not be estimated for a subject due to the nature of the subject's PK profile. | hours | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine) | Ketorolac Tromethamine (Given Alone) | 2128 | Standard Deviation 1042.5 | ng/mL | |
| Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine) | Fluticasone Propionate + Ketorolac Tromethamine | 1948 | Standard Deviation 1018.3 | ng/mL | |
| Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine) | Ketorolac Tromethamine (Given Alone) | 0.750 | Full Range 0.25 to 1.00 | hours | |
| Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine) | Fluticasone Propionate + Ketorolac Tromethamine | 0.750 | Full Range 0.25 to 1.00 | hours | |
| AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine). | Ketorolac Tromethamine (Given Alone) | 7991 | Standard Deviation 4364.2 | ng*hours/mL | |
| AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine). | Fluticasone Propionate + Ketorolac Tromethamine | 7610 | Standard Deviation 4076.8 | ng*hours/mL | |
| AUC Inf (the AUC From Time Zero to Infinity, Where Possible) | Ketorolac Tromethamine (Given Alone) | 8970 | Standard Deviation 4575 | ng*hours/mL | |
| AUC Inf (the AUC From Time Zero to Infinity, Where Possible) | Fluticasone Propionate + Ketorolac Tromethamine | 8276 | Standard Deviation 4380.7 | ng*hours/mL | |
| t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible) | Ketorolac Tromethamine (Given Alone) | 5.95 | Standard Deviation 2.105 | hours | |
| t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible) | Fluticasone Propionate + Ketorolac Tromethamine | 5.49 | Standard Deviation 2.004 | hours |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Study Participants | 36 | |
| Overall Study | COMPLETED | All Study Participants | 36 | |
| Overall Study | NOT COMPLETED | All Study Participants | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Ketorolac Tromethamine (Given Alone) | 1 | 36 | 1 |
| other | Fatigue | General disorders | Fluticasone Propionate + Ketorolac Tromethamine | 2 | 36 | 2 |
| other | Headache | Nervous system disorders | Ketorolac Tromethamine (Given Alone) | 4 | 36 | 5 |
| other | Headache | Nervous system disorders | Fluticasone Propionate + Ketorolac Tromethamine | 1 | 36 | 1 |
| other | Somnolence | Nervous system disorders | Ketorolac Tromethamine (Given Alone) | 1 | 36 | 1 |
| other | Somnolence | Nervous system disorders | Fluticasone Propionate + Ketorolac Tromethamine | 4 | 36 | 4 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Ketorolac Tromethamine (Given Alone) | 2 | 36 | 2 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Fluticasone Propionate + Ketorolac Tromethamine | 0 | 36 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketorolac Tromethamine (Given Alone) | ||
| Total, all-cause mortality | Fluticasone Propionate + Ketorolac Tromethamine | ||
| Total, other adverse events | Ketorolac Tromethamine (Given Alone) | 8 | 36 |
| Total, other adverse events | Fluticasone Propionate + Ketorolac Tromethamine | 7 | 36 |
| Total, serious adverse events | Ketorolac Tromethamine (Given Alone) | 0 | 36 |
| Total, serious adverse events | Fluticasone Propionate + Ketorolac Tromethamine | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ketorolac Tromethamine (Given Alone) vs Fluticasone Propionate + Ketorolac Tromethamine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01365611
GET https://conductscience.org/api/trials/v1/NCT01365611/registered