efficacy and safety evaluation of transtec for pain therapy such as first line opioid in patients afected by solid tumors with CT treatment . Fase IV study - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001679-39-IT

Enrollment

Registered

2006-12-20

Start date

2006-02-16

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer pain refractary to therapy without opioids MedDRA version: 9.1 Level: HLGT Classification code 10027655 Term: Miscellaneous and site unspecified neoplasms malignant and unspecified

Interventions

Trade Name: TRANSTEC*5CER 20MG 35MCG/H Pharmaceutical Form: Transdermal patch INN or Proposed INN: Buprenorphine CAS Number: 52485-79-7 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 18-80 cancer PS 8804; 2 VAS 8805; 60 mm CT therapy 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - buprenorfin allergy - patients with miastenia gravis or delirium tremens - pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: efficacy of treatment;Secondary Objective: pain free survival;Primary end point(s): pain free survival at six months after therapy with transtec	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026