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NCT02125643 · ClinicalTrials.gov registry record · Phase 1

EIMD Mechanisms Causing Force Loss

A Phase 1 study, sponsored by University of Oklahoma.

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT02125643: Clinical Trial Phase 1 study, sponsored by University of Oklahoma.

NCT02125643 is a Phase 1 study that was terminated before completion, run by University of Oklahoma. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02125643, a Phase 1 study, was terminated before completion, sponsored by University of Oklahoma.

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

We have hypothesized: 1) Caffeine will increase maximal voluntary strength compared to placebo in undamaged muscle. 2) Caffeine will increase muscle activation compared to placebo in undamaged muscle. 3) Caffeine will enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in undamaged muscle. 4) Caffeine will raise the pressure-pain threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in undamaged muscle. 5) Caffeine will reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz strength ratio, compared to placebo in undamaged muscle. 6) Caffeine will increase maximal voluntary strength compared to placebo in damaged muscle. 7) Caffeine will increase muscle activation compared to placebo in damaged muscle. 8) Caffeine will enhance spinal excitability (indicated by an enhanced H-reflex) compared to placebo in damaged muscle. 9) Caffeine will raise the pressure-pain threshold (indicating decreased pain sensitivity) in the calf muscle compared to placebo in damaged muscle. 10) Caffeine will reduce the amount of low-frequency fatigue, indicated by an enhanced 20-100 hertz strength ratio, compared to placebo in damaged muscle. The proposed research will determine the effects of a 5mg/kg body weight dose of caffeine on muscular strength, activation, H-reflex function, and excitation-contraction coupling before and after exercise-induced muscle damage. The long term objectives are to gain a better understanding of caffeine and its affects following exercise-induced muscle damage allowing us to understand how caffeine is mechanistically interacting with functions of the body.

Primary Outcome

Measure for maximal voluntary strength is in kilograms (kg) Change in maximal voluntary strength between base line and 24 hours, base line and 48 hours, and 24 and 48 hours - after ingesting caffeine/placebo in a counterbalanced manner in the undamaged state Change in maximal voluntary strength between base line and 24 hours, base line and 48 hours, and 24 and 48 hours - after ingesting caffeine/placebo in a counterbalanced manner following damaging protocol

Interventions

  • DRUG Caffeine
  • OTHER Flour

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2014-08
Est. Completion 2015-05
Phase Phase 1
University of Oklahoma

358 total trials

Why NCT02125643 stopped before completion

NCT02125643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Caffeine is the first listed.

NCT02125643 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02125643 about?

NCT02125643 is a clinical study titled "EIMD Mechanisms Causing Force Loss". We have hypothesized: 1) Caffeine will increase maximal voluntary strength compared to placebo in undamaged muscle. 2) Caffeine will increase muscle activation compared to placebo in undamaged muscle. 3) Caffeine will enhance spinal excitability (indicated by an enhanced H-reflex) compared to placeb...

What is the current status of trial NCT02125643?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-08. Estimated completion is 2015-05.

What interventions are being tested in trial NCT02125643?

The interventions under investigation include: Caffeine (DRUG), Flour (OTHER).

Who is sponsoring clinical trial NCT02125643?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02125643's enrollment target sits among peer trials

3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02125643, the US trial registry maintained by the National Library of Medicine. NCT02125643 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.