Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
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|ClinicalTrials.gov Identifier: NCT00236327|
Recruitment Status : Terminated (Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable.)
First Posted : October 12, 2005
Last Update Posted : May 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: fentanyl||Phase 4|
Patients with cancer pain are frequently under-medicated with morphine. This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine. The first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication. The dose is determined by the patient with oversight by the investigator, and rescue oral morphine medication can be used when necessary. The patient records all medication use in a diary and fills out questionnaires concerning pain control, intestinal function (constipation) and overall quality of life. The hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication.
Individualized doses, with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch; oral morphine as rescue medication for pain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting|
|Study Start Date :||June 2003|
|Actual Study Completion Date :||May 2004|
- Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.
- Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236327
|Study Director:||Janssen-Cilag S.A.S. Clinical Trial||Janssen Cilag S.A.S.|