Clinical trial NCT00346047: Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Low Back Pain
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Mundipharma Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2006-06-29
Enrollment: 238
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: The time to the development of inadequate analgesia.
timeFrame: Up to 12weeks
Secondary outcomes:
measure: Percentage of subjects who developed inadequate analgesia, 'Average pain over the last 24 hours' scores
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Ichikawa
country: Japan
facility: Investigational Site
state: Chiba
city: Matsudo
country: Japan
facility: Investigational Site
state: Chiba
city: Noda
country: Japan
facility: Investigational Site
state: Chiba
city: Asakura
country: Japan
facility: Investigational Site
state: Fukuoka
city: Kasuya
country: Japan
facility: Investigational Site
state: Fukuoka
city: Takasaki
country: Japan
facility: Investigational Site
state: Gunma
city: Sapporo
country: Japan
facility: Investigational Site
state: Hokkaido
city: Kobe
country: Japan
facility: Investigational Site
state: Hyogo
city: Yuki
country: Japan
facility: Investigational Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Investigational Site
state: Ishikawa
city: Komatsu
country: Japan
facility: Investigational Site
state: Ishikawa
city: Hanamaki
country: Japan
facility: Investigational Site
state: Iwate
city: Morioka
country: Japan
facility: Investigational Site
state: Iwate
city: Yokohama
country: Japan
facility: Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Investigational Site
state: Miyagi
city: Yao
country: Japan
facility: Investigational Site
state: Osaka
city: Koshigaya
country: Japan
facility: Investigational Site
state: Saitama
city: Tokorozawa
country: Japan
facility: Investigational Site
state: Saitama
city: Hikone
country: Japan
facility: Investigational Site
state: Shiga
city: Adachi
country: Japan
facility: Investigational Site
state: Tokyo
city: Arakawa
country: Japan
facility: Investigational Site
state: Tokyo
city: Edogawa
country: Japan
facility: Investigational Site
state: Tokyo
city: Itabashi
country: Japan
facility: Investigational Site
state: Tokyo
city: Ota
country: Japan
facility: Investigational Site
state: Tokyo
city: Suginami
country: Japan
facility: Investigational Site
state: Tokyo
city: Toshima
country: Japan
facility: Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Investigational Site
city: Niigata
country: Japan
facility: Investigational Site
city: Osaka
country: Japan
facility: Investigational Site
Study officials:
affiliation: Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K.
name: Mutsukuni Kataoka
role: STUDY_CHAIR
References: