NCT01816243

Brief Summary

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 Thai participants with chronic (lasting a long time) non-malignant (non-cancerous) pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_4 chronic-pain

Timeline
Completed

Started Apr 2004

Typical duration for phase_4 chronic-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 11, 2013

Completed
Last Updated

April 28, 2014

Status Verified

April 1, 2014

Enrollment Period

3.9 years

First QC Date

March 19, 2013

Results QC Date

April 12, 2013

Last Update Submit

April 9, 2014

Conditions

Chronic Pain

Keywords

Chronic PainChronic Non-Malignant PainTTS-fentanylDurogesic

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Pain Intensity Rating at Day 15

    Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.

    Baseline and Day 15

  • Change From Baseline in Pain Intensity Rating at Day 30

    Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.

    Baseline and Day 30

Secondary Outcomes (2)

  • Number of Participants With Investigator's Global Assessment

    Day 30

  • Number of Participants With Participant's Global Assessment

    Day 30

Study Arms (1)

Transdermal Therapeutic System (TTS)-fentanyl

EXPERIMENTAL

Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. Oral morphine syrup is allowed to titrate the dose of TTS-fentanyl. The study duration will be 30 days after first patch application.

Drug: TTS-FentanylDrug: Morphine

Interventions

TTS-FentanylDRUG

Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. The study duration will be 30 days after first patch application.

Also known as: Durogesic
Transdermal Therapeutic System (TTS)-fentanyl
MorphineDRUG

Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate dose titration. It is expected that most of the participants will be titrated to an appropriate dose of TTS-fentanyl within 1 week.

Transdermal Therapeutic System (TTS)-fentanyl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with chronic non-malignant pain (of any etiology except for headaches or central spinal cord mediated pain) with moderate (medium level of seriousness) to severe (very serious, life threatening) pain that requires treatment with a potent opioid
  • Participants must also be currently treated with short or long acting opioid medications other than Transdermal Therapeutic System (TTS)-fentanyl at a dose less than or equal to 134 milligram per day (mg/day) of oral morphine (or an equianalgesic dose of another opioid), participants may have been treated with TTS-fentanyl in the past
  • Participants who had side effects after receiving Non Steroidal Anti-inflammatory Drugs (NSAIDs)
  • Participants who failed from other treatments such as operation or lack of efficacy of current treatment
  • Participants with spinal cord stimulators may enroll, provided that they turn the spinal cord stimulator off for the duration of the trial, or leave it continually on for the duration of the trial

You may not qualify if:

  • History of allergy, hypersensitivity, or lack of ability to tolerate fentanyl
  • Skin disease that precludes 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 narcotic (strong habit-forming drug that stops pain and depresses the central nervous system) therapy
  • Pregnancy or breast-feeding female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anesthesia, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Thailand

Location

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

FentanylMorphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

Some limitations of this study were non randomization and uncontrolled design.

Results Point of Contact

Title
Medical Affairs Director
Organization
Medical Affairs, Janssen-Cilag (Thailand)
662-792-7200

Study Officials

  • Janssen-Cilag Ltd.,Thailand Clinical Trial

    Janssen-Cilag Ltd.,Thailand

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 22, 2013

Study Start

April 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 28, 2014

Results First Posted

June 11, 2013

Record last verified: 2014-04

Locations

TH(2)