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NCT02272725 · ClinicalTrials.gov registry record · Phase 3
Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances
A Phase 3 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
NCT02272725: Completed Phase 3 study, sponsored by Stanford University.
NCT02272725 is a Phase 3 study that has completed, run by Stanford University. The registered enrollment target is 91 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02272725, a Phase 3 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
Study Summary
The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over whether NSAID ingestion during endurance events contributes to acute kidney injury. Endurance events often ignite a "perfect storm" of physiologic insults- heat stress, dehydration, and myopathy- which can all negatively impact kidney function. There is a concern that NSAIDs may further potentiate these negative effects as well as contribute to EAH through its anti-diuretic affect. To date, no powered, prospective study has ever examined the effects of NSAIDs on either of these two biochemical outcomes Ultramarathon endurance events, defined as any race longer than a marathon (26.2 miles), are increasing in popularity, with a 10% increase in annual participants, and more than 69,000 finishers worldwide in 2013. Considerable literature has documented alterations in serum biochemical profiles of these endurance athletes, with consistent evidence of elevated serum creatinine (Cr) levels in healthy race finishers as well as those seeking medical care. While acute renal failure in ultramarathon runners is a rare occurrence, acute kidney injury is common, ranging from 34% in a single-stage ultramarathon to 55-80% in multi-stage ultramarathons. The evidence is equivocal regarding NSAID ingestion and AKI. One study showed that runners who ingested NSAIDs prior to marathons had greater post-race creatinine levels than matched controls as well as higher rates of hospitalization and acute renal failure. However, this contrasts with several other studies that showed a marked lack of difference in creatinine levels or development of acute kidney injury between NSAID users and non-users during ultramarathons. The only randomized trial to date on this subject found no difference in serum creatinine levels betw
Interventions
- DRUG Placebo
- DRUG Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2015-03 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02272725
The ClinicalTrials.gov registry entry for NCT02272725 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02272725 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02272725 about?
NCT02272725 is a clinical study titled "Non-steroidal Anti-inflammatory Affect on Kidneys in Endurance Distances". The specific aim of this study is to evaluate the safety of non-steroidal anti-inflammatory drugs (NSAIDs) and their impact on renal function and/or contribution to exercise-associated hyponatremia (EAH) during an ultramarathon foot race. There is currently much debate over whether NSAID ingestion d...
What is the current status of trial NCT02272725?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2015-03. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02272725?
The interventions under investigation include: Placebo (DRUG), Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT02272725?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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