Trial · NCT02272725
Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances
NCT02272725, Phase 3, Completed, Stanford University; results first posted 2017-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances. Trials, record NCT02272725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02272725
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances
- NCT number
- NCT02272725
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Acute Kidney Injury, Exercise-associated Hyponatremia, Perceived Exertion
- Interventions
- Ibuprofen, Placebo
- First posted
- 2014-10-23
- Last updated
- 2018-12-12
- Results first posted
- 2017-05-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute Kidney Injury | participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours | The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event. |
| Secondary | Perceived Exertion | participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours | A Borg score of perceived exertion will be measured at the finish line immediately following completion of a 50 mile ultramarathon to measure what affect ibuprofen had on perceived exertion as analgesia may have made the endurance event perceived as less exertional. Scores range from 7 - 20, with higher scores indicative of greater amount of exertion. |
| Secondary | Exercise-Associated Hyponatremia | participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours | The count of participants experiencing exercise-associated hyponatremia (defined as \< 135 mEq) will be estimated from measured point-of-care blood test at the finish line immediately following completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Acute Kidney Injury | participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Perceived Exertion | participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours | units on a scale | MEAN | |
| SECONDARY | Exercise-Associated Hyponatremia | participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Acute Kidney Injury | Placebo | 16 | Participants | ||
| Acute Kidney Injury | Ibuprofen | 22 | Participants | ||
| Perceived Exertion | Placebo | 15.96 | Standard Deviation 2.6 | units on a scale | |
| Perceived Exertion | Ibuprofen | 15.99 | Standard Deviation 2.5 | units on a scale | |
| Exercise-Associated Hyponatremia | Placebo | 7 | Participants | ||
| Exercise-Associated Hyponatremia | Ibuprofen | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | STARTED | Ibuprofen | 42 | |
| Overall Study | COMPLETED | Placebo | 47 | |
| Overall Study | COMPLETED | Ibuprofen | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Ibuprofen | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 47 |
| Total, all-cause mortality | Ibuprofen | 0 | 42 |
| Total, other adverse events | Placebo | 0 | 47 |
| Total, other adverse events | Ibuprofen | 0 | 42 |
| Total, serious adverse events | Placebo | 0 | 47 |
| Total, serious adverse events | Ibuprofen | 0 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28679502 | RESULT |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ibuprofen vs Placebo: Acute Kidney Injury | Trial comparisons |
| Ibuprofen vs Placebo: Exercise-Associated Hyponatremia | Trial comparisons |
| Ibuprofen vs Placebo: deaths from any cause | Trial comparisons |
| Ibuprofen vs Placebo: serious adverse events | 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/NCT02272725
GET https://conductscience.org/api/trials/v1/NCT02272725/registered