NCT00346047

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P25-P50 for phase_3 low-back-pain

Timeline
Completed

Started May 2006

Geographic Reach
1 country

29 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

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

1.2 years

First QC Date

June 27, 2006

Last Update Submit

April 11, 2008

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • The time to the development of inadequate analgesia.

    Up to 12weeks

Secondary Outcomes (1)

  • Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores

    Up to 12 weeks

Study Arms (2)

0

PLACEBO COMPARATOR
Drug: Placebo

1

EXPERIMENTAL
Drug: Buprenorphine Transdermal System

Interventions

PlaceboDRUG

Corresponding placebo is applied for 12weeks

0
Buprenorphine Transdermal SystemDRUG

Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks

1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females age 20 years or older.
  • Clinical diagnosis of low back pain for 4 weeks or longer with non-malignant pain etiology.

You may not qualify if:

  • Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to low back pain, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, osteoarthritis and diabetic neuropathy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Investigational Site

Ichikawa, Chiba, Japan

Location

Investigational Site

Matsudo, Chiba, Japan

Location

Investigational Site

Noda, Chiba, Japan

Location

Investigational Site

Asakura, Fukuoka, Japan

Location

Investigational Site

Fukuoka, Fukuoka, Japan

Location

Investigational Site

Wakasugi, Fukuoka, Japan

Location

Investigational Site

Takasaki, Gunma, Japan

Location

Investigational Site

Sapporo, Hokkaido, Japan

Location

Investigational Site

Kobe, Hyōgo, Japan

Location

Investigational Site

Yūki, Ibaraki, Japan

Location

Investigational Site

Kanazawa, Ishikawa-ken, Japan

Location

Investigational Site

Komatsu, Ishikawa-ken, Japan

Location

Investigational Site

Hanamaki, Iwate, Japan

Location

Investigational Site

Morioka, Iwate, Japan

Location

Investigational Site

Yokohama, Kanagawa, Japan

Location

Investigational Site

Sendai, Miyagi, Japan

Location

Investigational Site

Niigata, Niigata, Japan

Location

Investigational Site

Osaka, Osaka, Japan

Location

Investigational Site

Yao, Osaka, Japan

Location

Investigational Site

Koshigaya, Saitama, Japan

Location

Investigational Site

Tokorozawa, Saitama, Japan

Location

Investigational Site

Hikone, Shiga, Japan

Location

Investigational Site

Adachi City, Tokyo, Japan

Location

Investigational Site

Arakawa City, Tokyo, Japan

Location

Investigational Site

Edogawa City, Tokyo, Japan

Location

Investigational Site

Ōta-ku, Tokyo, Japan

Location

Investigational Site

Suginami, Tokyo, Japan

Location

Investigational Site

tabashi City, Tokyo, Japan

Location

Investigational Site

Toshima City, Tokyo, Japan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mutsukuni Kataoka

    Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

May 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations

JP(29)