An Open-Label, Multicenter Study to Evaluate the Safety/Tolerability and Clinical Utility of Low-Dose TTS-Fentanyl D-TRANS in Taiwan Patients With Cancer Pain

Condition(s) targeted: Pain

Intervention: Durogesic DTRANS (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Johnson & Johnson Taiwan Ltd

Official(s) and/or principal investigator(s):
Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Taiwan Ltd

Overall contact:
This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

This is a single-arm, non-randomized, open-label study. 600 eligible patients will be enrolled and scheduled to return at Days 0, 7, 14 and 28 for safety and clinical utility assessments. The primary objective of this trial is to evaluate the tolerability of low-dose TTS-F D-TRANS by observing the dropout rate due to Adverse events. Safety assessments will consist of physical examinations and vital signs, clinical laboratory evaluation, and monitoring for adverse events. Pain severity, Patients' Quality of Life, Dosing and Titration Requirements, Investigator's Global Assessment and Patients' Satisfaction will be evaluated as clinical utility. Throughout the 4-week study, dose adjustments are permitted at each patch renewal (every 3 days). The initial dose of TTS-F will be administered at 12 microgram per hour. The dose should be titrated in consultation with the treating physician and according to the subject's analgesic requirement, with the intention of maintaining his/her pain score at 2 or less by mean of the past 3 days' Numeric Rating Scale (NRS). Oral morphine could be used as rescue medication if necessary for breakthrough pain.

Official title: An Open-Label, Multicenter Study to Evaluate the Safety/Tolerability and Clinical Utility of Low-Dose TTS-Fentanyl D-TRANS in Taiwan Patients With Cancer Pain

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Dropout rate due to adverse events (AEs) at day 0, 7, 14 and 28.

Secondary outcome: Clincial Utility and Safety at day 0, 7, 14 and 28.

Detailed description: Fentanly, a synthetic opioid, has been extensively and successfully used for the control of chronic pain. The transdermal therapeutic system (TTS; Durogesic) was developed and approved in the US in 1991, and has since been approved in approximately 45 countries. The system consists of a rate-controlling membrane providing constant release of fentanyl at a controlled rate for up to 72 hour, making it well suited to the treatment of chronic pain. New matrix form "Durogesic DTRANS", will use in the same indication with the old form. This controlled-release patch formulation offers the advantage of achieving more consistent drug delivery in a convenient, noninvasive way and could contribute to improved patient adherence to therapy. This study is designed to investigate the safety/tolerability and clinical utility of low dose TTS-F in Taiwan patients with cancer pain, meanwhile, demonstrate the drop out rate will be decreased by initiating therapy with12 microgram per hour instead of with 25 microgram per hour. This is a single-arm, non-randomized, open-label study. 600 eligible patients will be enrolled and scheduled to return at Days 0, 7, 14 and 28 for safety/tolerability and clinical utility assessments. The primary endpoint is the dropout rate due to Adverse events. Safety assessments consist of physical examinations and vital signs, clinical laboratory evaluation, and monitoring for adverse events. Pain severity, patients' Quality of Life, Dosing and Titration Requirements, Investigator's Global Assessment and Patients' Satisfaction will be evaluated as clinical utility. The screening will last up to three weeks. Patients with cancer pain who meet entrance criteria for the study will be identified. The study will be explained and informed consent will be obtained. Patients who have met the criteria at screening will start approximately 28-day treatment. Throughout the treatment, dose adjustments are permitted at each patch renewal (every 3 days).The initial dose of TTS-F will be administered at 12 microgram per hour. The dose should be titrated in consultation with the treating physician and according to the patient's analgesic requirement, with the intention of maintaining his/her pain score at 2 or less by mean of the past 3 days' Numeric Rating Scale (NRS). Oral morphine could be used as rescue medication if necessary for breakthrough pain. Steroidal anti-inflammatory drugs, NSAIDs, adjuvants (antidepressants and antiepletics, laxatives, mild antiemetics and 5HT3-blockers) are allowed to be prescribed by the treating physician deems the necessity. The lowest dose is designated as 12 microgram per hour (however, the actual dose is 12. 5 microgram per hour) to distinguish it from a 125 microgram per hour dose that could be prescribed by using multiple patches. Each patch should be applied to nonirritated, non-irradiated, and hair-free skin, on a flat surface such as the chest, back, flank, or upper arm, and worn for 72 hour.

The initial dose of DTRANS transdermal patch will be 12 microgram per hour. The dose should be titrated in consultation with the treating physician and according to the patient's analgesic requirement, with the intention of maintaining his/her pain score at 2 or less by mean of the past 3 days' Numeric Rating Scale. The duration of the treatment will be 28 days.

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients who are diagnosed with cancer

- Histologically confirmed malignancy

- Patients who are able to communicate effectively with study personnel

- Patients who have intolerable cancer pain (pain score >= 4)

- Patients who have an estimated life expectancy of at least 30 days

Exclusion Criteria:

- Patients who have already received regular treatment with an strong opioid for their

pain before entering the study

- Patients who have already received tramadol treatment over 200 mg for their pain

before entering the study

- Patients with significant abnormalities in hepatic or renal function which would, in

the opinion of the investigator, prevent the patients involvement in the study

- Patients with significant clinical abnormalities in CNS, respiratory or cardiovascular

function, which in the investigators judgment prevents participation in the study

- Patients who have active skin disease precluding application of the transdermal

system

- Patients who have opioid abuse, and contraindication to opioids

- Patients who at entry, have treatments planned which may alter abruptly, the degree or

nature of pain experienced (eg radiotherapy, neurological techniques, surgery), which in the investigators judgment prevents participation in the study

- Patients who require the concomitant administration of an MAOI

This study is not yet recruiting patients. Please check back for future recruiting sites, or email, Email: info1@veritasmedicine.com

Last updated: January 29, 2009