What is the clinical evidence from this study?

Study design: RCT. Population: healthy volunteers (n=18). Intervention: pentoxyverine (POV) vs. placebo. Primary outcome: QTc interval (95% CI upper limit 8.5 ms).

What question did this study set out to answer?

This research aims to investigate whether pentoxyverine affects the electrocardiogram, specifically the QTc interval.

March 24, 2026

The antitussive pentoxyverine (POV) does not affect the electrocardiogram (ECG), and in particular not the corrected QT (QTc) interval: Results from a phase I clinical trial

Key Result

A supratherapeutic single oral dose of 121.5mg pentoxyverine did not affect the ECG or QTc interval in healthy subjects (upper limit of the CI for the difference to placebo was 8.5 ms).

Key Points

This research aims to investigate whether pentoxyverine affects the electrocardiogram, specifically the QTc interval.
Randomised, placebo-controlled, single-blind, 2-way crossover trial
Involves 18 healthy volunteers (9 male, 9 female)
Participants received a supratherapeutic oral dose of 121.5mg pentoxyverine
ECGs were recorded continuously over 24 hours and analyzed for various intervals
No significant changes in QTcN or QTcF observed after administration of pentoxyverine
QTcN and QTcF changes to baseline remained below 2.3 ms
Upper limit of the Confidence Interval of difference to placebo was 8.5 ms
Other ECG intervals (QT, HR, PQ, QRS) showed no relevant changes

Study Design

Type

RCT (n=18)

Blinding

single-blind

Randomization

randomised, 2-way crossover

Structured PICO

Does a supratherapeutic single oral dose of pentoxyverine prolong the QTc interval or affect other ECG parameters in healthy volunteers?

Population

18 healthy volunteers (9 female and 9 male)

Intervention

Supratherapeutic single oral dose of 121.5 mg pentoxyverine (192 mg pentoxyverine citrate in 90 ml syrup)

Comparator

Placebo

Outcome

Effects on the ECG including the QTc interval (QTcN and QTcF) over 24 hourssafety

A supratherapeutic single dose of pentoxyverine does not cause clinically relevant QTc prolongation or other ECG abnormalities in healthy subjects.

Abstract

Preclinical data have shown that high concentrations of the antitussive POV can affect hERG channels in vitro , but do not alter the QT interval even at very high doses/plasma levels in dogs in vivo . This randomised, placebo-controlled, single-blind, 2-way crossover clinical trial in 18 (9 female and 9 male) healthy volunteers investigated effects of POV on the ECG including the QTc interval following the administration of a supratherapeutic single oral dose of 121.5mg POV (192mg POV citrate in 90ml syrup). This single dose corresponds to the maximum total daily dose recommended for the treatment of dry cough (20mg to 30mg POV up to 4 times daily). ECGs were continuously recorded over 24h, and triplicate 12-lead ECGs of 10s duration each were extracted. PR, QRS, QT, QTcN, QTcF, and RR intervals as well as heart rate were determined (QTc: QT interval corrected for influences of HR (QTcF=Fridericia formula, QTcN=population method)). Neither QTcN nor QTcF showed notable findings (new onset of QTc intervals>450ms, changes from baseline in QTc > 30ms) regarding absolute or relative prolongations of the QTc. QTcN and QTcF changes to baseline remained below 2.3 ms throughout the observation period. The highest upper limit of the Confidence Interval of the difference to placebo was 8.5 ms. Also QT, HR, PQ, and QRS did not reveal any relevant findings. No clinically relevant abnormal morphological ECG findings were documented for POV. POV given as a supratherapeutic single dose (121.5mg, corresponding to 192 mg POV citrate) did not affect the ECG (in particular not the QTc-interval) in healthy subjects.

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