Trial · NCT01365650
Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis
NCT01365650, Phase 1, Completed, Egalet Ltd; results first posted 2015-07-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis. Trials, record NCT01365650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01365650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis
- NCT number
- NCT01365650
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Egalet Ltd
- Conditions
- Allergic Rhinitis
- Interventions
- Ketorolac Tromethamine, Oxymetazoline Hydrochloride, Fluticasone Propionate
- First posted
- 2011-06-03
- Last updated
- 2018-03-06
- Results first posted
- 2015-07-23
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) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac. |
| Primary | Tmax (the Time to Maximum Concentration) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac. |
| Primary | AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac. |
| Primary | AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac. |
| Primary | t1/2z (the Terminal Half-life, Where Possible) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac. |
| Primary | MRT (the Mean Residence Time) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac. |
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) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | ng/mL | MEAN | |
| PRIMARY | Tmax (the Time to Maximum Concentration) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | 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) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | ng*h/mL | MEAN | |
| PRIMARY | AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | ng*h/mL | MEAN | |
| PRIMARY | t1/2z (the Terminal Half-life, Where Possible) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | hours | MEAN | |
| PRIMARY | MRT (the Mean Residence Time) | Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine | hours | MEAN |
Source ClinicalTrials.gov
Results by group18
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) | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 1630.223 | Standard Deviation 653.599 | ng/mL | |
| Cmax (the Maximum Observed Plasma Concentration) | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 1729.393 | Standard Deviation 684.055 | ng/mL | |
| Cmax (the Maximum Observed Plasma Concentration) | Seven Days of Treatment With i.n. Fluticasone Propionate | 1617.810 | Standard Deviation 766.328 | ng/mL | |
| Tmax (the Time to Maximum Concentration) | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 1.000 | Full Range 0.25 to 2.00 | hours | |
| Tmax (the Time to Maximum Concentration) | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 1.250 | Full Range 0.75 to 2.05 | hours | |
| Tmax (the Time to Maximum Concentration) | Seven Days of Treatment With i.n. Fluticasone Propionate | 0.875 | Full Range 0.25 to 4.00 | hours | |
| AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose) | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 9001.8 | Standard Deviation 4011.2 | ng*h/mL | |
| AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose) | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 9310.3 | Standard Deviation 3200.2 | ng*h/mL | |
| AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose) | Seven Days of Treatment With i.n. Fluticasone Propionate | 8794.3 | Standard Deviation 4188.2 | ng*h/mL | |
| AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible) | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 9906.9 | Standard Deviation 4347.0 | ng*h/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment A | STARTED | Symptomatic Allergic Rhinitis | 24 | |
| Treatment A | COMPLETED | Symptomatic Allergic Rhinitis | 24 | |
| Treatment A | NOT COMPLETED | Symptomatic Allergic Rhinitis | 0 | |
| Treatment B | STARTED | Symptomatic Allergic Rhinitis | 24 | |
| Treatment B | COMPLETED | Symptomatic Allergic Rhinitis | 24 | |
| Treatment B | NOT COMPLETED | Symptomatic Allergic Rhinitis | 0 | |
| Treatment C | STARTED | Symptomatic Allergic Rhinitis | 24 | |
| Treatment C | COMPLETED | Symptomatic Allergic Rhinitis | 24 | |
| Treatment C | NOT COMPLETED | Symptomatic Allergic Rhinitis | 0 |
Source ClinicalTrials.gov
Adverse events27
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 | Lacrimation increased | Eye disorders | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 3 | 24 | 3 |
| other | Lacrimation increased | Eye disorders | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 0 | 24 | 0 |
| other | Lacrimation increased | Eye disorders | Seven Days of Treatment With i.n. Fluticasone Propionate | 2 | 24 | 2 |
| other | Nausea | Gastrointestinal disorders | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 0 | 24 | 0 |
| other | Nausea | Gastrointestinal disorders | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 3 | 24 | 4 |
| other | Nausea | Gastrointestinal disorders | Seven Days of Treatment With i.n. Fluticasone Propionate | 0 | 24 | 0 |
| other | Urinary tract infection | Infections and infestations | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 2 | 24 | 2 |
| other | Urinary tract infection | Infections and infestations | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 0 | 24 | 0 |
| other | Urinary tract infection | Infections and infestations | Seven Days of Treatment With i.n. Fluticasone Propionate | 2 | 24 | 2 |
| other | Dizziness | Nervous system disorders | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 2 | 24 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single i.n. Dose of 30 mg Ketorolac Tromethamine | ||
| Total, all-cause mortality | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | ||
| Total, all-cause mortality | Seven Days of Treatment With i.n. Fluticasone Propionate | ||
| Total, other adverse events | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 17 | 24 |
| Total, other adverse events | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 22 | 24 |
| Total, other adverse events | Seven Days of Treatment With i.n. Fluticasone Propionate | 17 | 24 |
| Total, serious adverse events | Single i.n. Dose of 30 mg Ketorolac Tromethamine | 0 | 24 |
| Total, serious adverse events | Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a | 0 | 24 |
| Total, serious adverse events | Seven Days of Treatment With i.n. Fluticasone Propionate | 0 | 24 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01365650
GET https://conductscience.org/api/trials/v1/NCT01365650/events?page=2