EUCTR2015-000618-23-SE
Active, not recruiting
Phase 1
Treatment of osteoradionecrosis (ORN) with pentoxifylline and a-tocopherol (PENTO)
Västra Götalandsregionen/NÄ0 sites40 target enrollmentMarch 3, 2015
ConditionsOsteoradionecrosisMedDRA 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Osteoradionecrosis
- Sponsor
- Västra Götalandsregionen/NÄ
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Tumor\-free, prior radiation in head and neck region
- •Tissue\-scale (SH index) S0H2\-3 or S1H1\-3
- •Men and women age \=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 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 20
Exclusion Criteria
- •Drug interactions with study medication
- •Inability to swallow tablets
- •Participation in a simultaneous and similar study
- •Alcohol or drug abuse
- •Mental illness or other conditions that the doctor/dentist deems incompatible with the study protocol
Outcomes
Primary Outcomes
Not specified
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