Clinical trial NCT00345787: Comparison of BTDS (Buprenorphine Transdermal System) and Placebo in Osteoarthritic 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 Osteoarthritic Pain of the Hip or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Osteoarthritis
Keywords: Osteoarthritic Pain
Lead sponsor: Mundipharma Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2006-06-29
Enrollment: 262
Sex: ALL
Minimum age (years): 40
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 osteoarthritic pain of the hip or knee.

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 osteoarthritic pain of the hip or knee 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 ages 40 years or older.
* Clinical diagnosis of osteoarthritis (OA) of the hip or knee.

Exclusion Criteria:

* Subjects who have a current or past history of chronic disease(s), in addition to OA, requiring frequent analgesic therapy (e.g. headache, fibromyalgia, gout, rheumatoid arthritis, low back pain, 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: 12weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Investigational Site
state: Aichi
city: Okazaki
country: Japan
facility: Investigational Site
state: Aichi
city: Ichikawa
country: Japan
facility: Investigational Site
state: Chiba
city: Matsudo
country: Japan
facility: Investigational Site
state: Chiba
city: Nagareyama
country: Japan
facility: Investigational Site
state: Chiba
city: Annaka
country: Japan
facility: Investigational Site
state: Gunma
city: Takasaki
country: Japan
facility: Investigational Site
state: Gunma
city: Chitose
country: Japan
facility: Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site
state: Hokkaido
city: Kako
country: Japan
facility: Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Investigational Site
state: Hyogo
city: Yokohama
country: Japan
facility: Investigational Site
state: Kanagawa
city: Joyo
country: Japan
facility: Investigational Site
state: Kyoto
city: Sendai
country: Japan
facility: Investigational Site
state: Miyagi
city: Isahaya
country: Japan
facility: Investigational Site
state: Nagasaki
city: Kasukabe
country: Japan
facility: Investigational Site
state: Saitama
city: Koshigaya
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: Koto
country: Japan
facility: Investigational Site
state: Tokyo
city: Setagaya
country: Japan
facility: Investigational Site
state: Tokyo
city: Suginami
country: Japan
facility: Investigational Site
state: Tokyo
city: Himi
country: Japan
facility: Investigational Site
state: Toyama
city: Kurobe
country: Japan
facility: Investigational Site
state: Toyama
city: Fukui
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: