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Clinical Trials/EUCTR2015-000887-32-SE
EUCTR2015-000887-32-SE
Active, not recruiting
Phase 1

Prophylactic treatment of osteoradionecrosis (ORN) with pentoxifylline and a-tocopherol (PENTO)

Västra Götalandsregionen/NÄ0 sites80 target enrollmentMay 11, 2015
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DrugsTrentalTokoferol

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Västra Götalandsregionen/NÄ
Enrollment
80
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 11, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Västra Götalandsregionen/NÄ

Eligibility Criteria

Inclusion Criteria

  • •Tissue\-scale (SH) index S0H2\-3 or S1H1\-3
  • •Men and women aged \=18 years
  • •Understand the Swedish speaking and writing
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 40
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 40

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

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Effect of pentoxifylline and vitamin E on osteoradionecrosisOsteoradionecrosisMedDRA version: 18.0Level: PTClassification code 10031264Term: OsteonecrosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 18.0Level: PTClassification code 10067352Term: OsteoradionecrosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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