NCT01774903

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 severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_4 low-back-pain

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

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

August 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 25, 2013

Completed
Last Updated

March 25, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

January 21, 2013

Results QC Date

February 18, 2013

Last Update Submit

February 18, 2013

Conditions

Low Back Pain

Keywords

Low Back PainTTS-fentanylDurogesic

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity at Day 15

    Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.

    Day 15

  • Pain Intensity at Day 30

    Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.

    Day 30

Secondary Outcomes (2)

  • Number of Participants With Investigator Global Assessment

    Day 30

  • Number of Participants With Participant Global Assessment

    Day 30

Study Arms (1)

TTS-fentanyl

EXPERIMENTAL
Drug: TTS-fentanyl

Interventions

TTS-fentanylDRUG

TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.

TTS-fentanyl

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

January 21, 2013

First Posted

January 24, 2013

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 25, 2013

Results First Posted

March 25, 2013

Record last verified: 2013-02

Locations

TH(1)