Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)
This study has been withdrawn prior to enrollment.
Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT00959400
First received: August 13, 2009
Last updated: June 9, 2011
Last verified: August 2009
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Purpose
Eligible patients who agree to participate will migrate from oral opioids to transdermal patches and be followed for four weeks. Oral morphine will be provided as pain rescue medication. The patients will inform the adverse events and rescue medication consumption. The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life questionary) will be filled before and after the use of Fentanest®. Patients showing benefit are eligible to a 3 weeks compassionate study.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Palliative Care |
Drug: Fentanyl Transdermal |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Primary Outcome Measures:
- Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand). [ Time Frame: 4 weeks folow-up ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Establish the correspondence between the dose of oral opioids available in Brazil and number of patches required. Establish directions for secure and effective migration from oral opioids to this formulation. Quality of life improvement (WHO-QOL-bref). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2009 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Fentanyl Transdermal |
Drug: Fentanyl Transdermal
Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours. Therefore paches must be changed every 3 days.
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female outpatients aged from 18 to 70 years with cancer chronic pain who received in the last 4 weeks at least 40 mg of oral morphine or equianalgesic dose of other opioids. If using adjuvant analgesics, these must be in stable doses in the last 4 weeks.
Exclusion Criteria:
- Life expectancy bellow 4 months;
- Karnofsky score < 60;
- Hypersensitivity to opioids or patches;
- Acute pain;
- Non cancer pain;
- Increased intracranial pressure;
- Conditions that prevent the patient to understand the study directions and/or give his consent;
- Neuromuscular disorders with increased risk of respiratory depression;
- Impossibility to receive rescue oral morphine; active infections;
- Fever;
- Pregnancy and nursing;
- Uncontrolled diabetes mellitus or arterial hypertension;
- Need of anticoagulation;
- Need to operate machines or vehicles;
- Important skin disorders;
- History of severe allergic reactions;
- BMI ≥ 35;
- Safety exams outrange;
- Participation in another clinical trial within the last 2 months;
- Investigator´s opinion.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959400
Locations
| Brazil | |
| Hospital Universitario da Universidade Federal do Maranhao | |
| Sao Luis, Maranhao, Brazil, 65020-070 | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp | |
| Botucatu, Sao Paulo, Brazil, 18618-970 | |
| Instituto Nacional de Cancer - Hospital do Cancer I | |
| Rio de Janeiro, Brazil, 20230-130 | |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP | |
| Sao Paulo, Brazil, 05403-000 | |
| Hospital A. C. Camargo | |
| Sao Paulo, Brazil, 01509-010 | |
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
More Information
No publications provided
| Responsible Party: | Eduardo Pagani, CRISTÁLIA PRODUTOS QUÍMICOS FARMACÊUTICOS LTDA |
| ClinicalTrials.gov Identifier: | NCT00959400 History of Changes |
| Other Study ID Numbers: | CRT059 |
| Study First Received: | August 13, 2009 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Keywords provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
|
Fentanyl Transdermal Pain Cancer |
Additional relevant MeSH terms:
|
Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 21, 2013