Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00279344

Enrollment

220

Registered

2006-01-19

Start date

2004-09-30

Completion date

2007-08-31

Last updated

2012-05-07

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

Conditions

Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

Brief summary

Primary objectives: * To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment * To assess the safety of FITpatch compared to standard opioid treatment Secondary objectives: * To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment * To assess Quality of life reported with FITpatch compared to standard opioid treatment

Interventions

DRUGFentanyl (Matrifen)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50. 1. Subject informed consent given. 2. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception. 3. No significant skin lesions on relevant surfaces on the body or diffuse skin diseases. 4. No impaired respiratory function nor neurological or psychiatric impairment. 5. No known abuse of drug, narcotic or alcohol. 6. Not pregnant or nursing. 7. Not hypersensitive/allergic to fentanyl or morphine. 8. No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness. 9. Not participating in other clinical trials.

Exclusion criteria

All

Design outcomes

Primary

Measure	Time frame
Primary:	—
To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment	—

Secondary

Measure	Time frame
Secondary:	—
To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026