At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 24 enrolled

Drug / intervention

Pentoxifylline and Tocopheroldrug

Likely dose

Pentoxifylline and Tocopherol 800 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02368457

NCT02368457Phase 4Completed

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Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment

Hospital Vall d'Hebron·interventional·Posted Feb 23, 2015·Updated Mar 22, 2018

In Brief

A Phase 4 clinical trial evaluating Pentoxifylline and Tocopherol for Osteoradionecrosis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms. Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteoradionecrosis

CountriesSpain

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

First PostedFeb 2015

Enrollment StartFeb 2016

Primary CompletionFeb 2016

Study CompletionJan 2018

TodayJul 2026

First PostedFeb 23, 2015

Enrollment StartFeb 1, 2016

Primary CompletionFeb 1, 2016

Study CompletionJan 1, 2018

TodayJul 2, 2026

Enrollment to primary: 0 daysPosted 11.4 years ago

Interventions

Pentoxifylline and Tocopheroldrug

pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).