Trial · NCT01363050
Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers
NCT01363050, Phase 1, Completed, Egalet Ltd; results first posted 2013-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers. Trials, record NCT01363050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01363050
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers
- NCT number
- NCT01363050
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Egalet Ltd
- Conditions
- Healthy Volunteers
- Interventions
- Ketorolac tromethamine
- First posted
- 2011-06-01
- Last updated
- 2017-03-16
- Results first posted
- 2013-05-03
Source ClinicalTrials.gov
Registered outcomes9
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 determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | Tmax (the Time to Maximum Concentration) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | Cmax,ss (the Maximum Observed Plasma Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | Tmax,ss (the Time to Maximum Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | Cmin,ss (the Minimum Observed Plasma Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | Tmin,ss (the Time to Minimum Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
| Primary | MRT (the Mean Residence Time | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac. |
Source ClinicalTrials.gov
Outcomes9
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 determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | ng/mL | MEAN |
| PRIMARY | Tmax (the Time to Maximum Concentration) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | hours | MEDIAN |
| PRIMARY | AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | ng*hours/mL | MEAN |
| PRIMARY | Cmax,ss (the Maximum Observed Plasma Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | ng/mL | MEAN |
| PRIMARY | Tmax,ss (the Time to Maximum Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | hours | MEDIAN |
| PRIMARY | Cmin,ss (the Minimum Observed Plasma Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | ng/mL | MEAN |
| PRIMARY | Tmin,ss (the Time to Minimum Concentration at Steady State) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | hours | MEDIAN |
| PRIMARY | AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state) | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | ng*hours/mL | MEAN |
| PRIMARY | MRT (the Mean Residence Time | Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses) | Two subjects were considered pharmacokinetic outliers and were excluded from the PK population. | hours | MEAN |
Source ClinicalTrials.gov
Results by group9
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) | Ketorolac Tromethamine | 1147.9 | Standard Deviation 186.0 | ng/mL | |
| Tmax (the Time to Maximum Concentration) | Ketorolac Tromethamine | 1.000 | Full Range 1.00 to 7.92 | hours | |
| AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose) | Ketorolac Tromethamine | 4713.8 | Standard Deviation 744.8 | ng*hours/mL | |
| Cmax,ss (the Maximum Observed Plasma Concentration at Steady State) | Ketorolac Tromethamine | 1382.6 | Standard Deviation 224.3 | ng/mL | |
| Tmax,ss (the Time to Maximum Concentration at Steady State) | Ketorolac Tromethamine | 1.000 | Full Range 1.00 to 3.00 | hours | |
| Cmin,ss (the Minimum Observed Plasma Concentration at Steady State) | Ketorolac Tromethamine | 367.7 | Standard Deviation 67.7 | ng/mL | |
| Tmin,ss (the Time to Minimum Concentration at Steady State) | Ketorolac Tromethamine | 0.000 | Full Range 0.00 to 8.00 | hours | |
| AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state) | Ketorolac Tromethamine | 6379.2 | Standard Deviation 1031.0 | ng*hours/mL | |
| MRT (the Mean Residence Time | Ketorolac Tromethamine | 3.368 | Standard Deviation 0.056 | hours |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketorolac Tromethamine | 15 | |
| Overall Study | COMPLETED | Ketorolac Tromethamine | 15 | |
| Overall Study | NOT COMPLETED | Ketorolac Tromethamine | 0 |
Source ClinicalTrials.gov
Adverse events16
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 | Ketorolac Tromethamine | 2 | 15 | 4 |
| other | Lip dry | Gastrointestinal disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
| other | Nausea | Gastrointestinal disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
| other | Catheter site haematoma | General disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
| other | Feeling cold | General disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
| other | Rhinitis | Infections and infestations | Ketorolac Tromethamine | 1 | 15 | 2 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
| other | Dizziness | Nervous system disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
| other | Headache | Nervous system disorders | Ketorolac Tromethamine | 3 | 15 | 4 |
| other | Paraesthesia | Nervous system disorders | Ketorolac Tromethamine | 1 | 15 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketorolac Tromethamine | ||
| Total, other adverse events | Ketorolac Tromethamine | 14 | 15 |
| Total, serious adverse events | Ketorolac Tromethamine | 0 | 15 |
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/NCT01363050
GET https://conductscience.org/api/trials/v1/NCT01363050/registered