An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis
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Purpose
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: TTS-fentanyl |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Efficacy and Safety of TTS-Fentanyl in Moderate to Severe Pain in Osteoarthritis Patients |
- Pain intensity at Day 15 [ Time Frame: Day 15 ] [ Designated as safety issue: No ]The pain intensity is assessed by using a 10 centimeter (cm) of Visual Analog Scale (VAS) from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.
- Pain intensity at Day 30 [ Time Frame: Day 30 ] [ Designated as safety issue: No ]The pain intensity is assessed by using a 10 cm of VAS from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.
- Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) score at Day 15 and Day 30 [ Time Frame: Day 15 and Day 30 ] [ Designated as safety issue: No ]The WOMAC questionnaire consists of 24 items scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain): pain (5 items), stiffness (2 items) and functional impairment (17 items).
| Enrollment: | 35 |
| Study Start Date: | October 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transdermal Therapeutic System (TTS)-fentanyl
TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
|
Drug: TTS-fentanyl
TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
|
Detailed Description:
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective (study following participants forward in time), study of TTS-fentanyl in participants with moderate to severe pain of osteoarthritis. The study will consist of 2 phases: screening phase up to 7 days before starting the treatment and treatment phase of 30 days. The first patch will be applied by investigator then by participants until 30 days. The dose of TTS-fentanyl can be increased, if needed, by 12.5 microgram per hour until adequate (reasonably good) pain control is achieved and taking into account the daily dose of supplemental paracetamol required by the participant. Other concomitant (given at the same time) analgesics (drug used to control pain) will not be used during this phase. Efficacy with regard to pain control will be recorded principally by the participant through questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with Visual Analog Scale (VAS) greater than or equal to 5
- Participants having moderate to severe pain (VAS greater than or equal to 5), which was not adequately controlled by weak opioids such as tramadol or codeine at optimal doses (at least 150 milligram [mg] per day for tramadol or 200 mg per day for codeine) for at least 7 consecutive days
- Participants who failed from other treatments such as operation or lack of efficacy of current treatment
Exclusion Criteria:
- Skin disease that prevents the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability
- History or suspicion of alcohol or drug abuse within the past 5 years
- History of cardiac, nervous system or respiratory disease which in the investigator's judgment precludes participation in the study because of the potential for respiratory depression
- Confusion, reduced level of consciousness, or concomitant (given at the same time) psychiatric disorder which, in the opinion of the investigator, could prevent participation in the trial
- Pregnant or breast-feeding female; female participants of child bearing potential without adequate contraception
Contacts and Locations More Information
No publications provided
| Responsible Party: | Janssen-Cilag Ltd.,Thailand |
| ClinicalTrials.gov Identifier: | NCT01774929 History of Changes |
| Other Study ID Numbers: | CR014536, FENPAI 4053 |
| Study First Received: | January 21, 2013 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Thailand: Food and Drug Administration, Ministry of Public Health |
Keywords provided by Janssen-Cilag Ltd.,Thailand:
|
Osteoarthritis Transdermal Therapeutic System (TTS)-fentanyl Durogesic |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases 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 19, 2013