NCT00345787

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started May 2006

Geographic Reach
1 country

28 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
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

1.3 years

First QC Date

June 27, 2006

Last Update Submit

April 11, 2008

Conditions

PainOsteoarthritis

Keywords

Osteoarthritic 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

    12weeks

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 20mg/patch is applied for 12weeks

1

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females ages 40 years or older.
  • Clinical diagnosis of osteoarthritis (OA) of the hip or knee.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Investigational Site

Nagoya, Aichi-ken, Japan

Location

Investigational Site

Okazaki, Aichi-ken, Japan

Location

Investigational Site

Ichikawa, Chiba, Japan

Location

Investigational Site

Matsudo, Chiba, Japan

Location

Investigational Site

Nagareyama, Chiba, Japan

Location

Investigational Site

Fukui-shi, Fukui, Japan

Location

Investigational Site

Annaka, Gunma, Japan

Location

Investigational Site

Takasaki, Gunma, Japan

Location

Investigational Site

Chitose, Hokkaido, Japan

Location

Investigational Site

Sapporo, Hokkaido, Japan

Location

Investigational Site

Kako, Hyōgo, Japan

Location

Investigational Site

Kobe, Hyōgo, Japan

Location

Investigational Site

Yokohama, Kanagawa, Japan

Location

Investigational Site

Jōyō, Kyoto, Japan

Location

Investigational Site

Sendai, Miyagi, Japan

Location

Investigational Site

Isahaya, Nagasaki, Japan

Location

Investigational Site

Osaka, Osaka, Japan

Location

Investigational Site

Kasukabe, Saitama, Japan

Location

Investigational Site

Koshigaya, 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

Koto, Tokyo, Japan

Location

Investigational Site

Setagaya City, Tokyo, Japan

Location

Investigational Site

Suginami, Tokyo, Japan

Location

Investigational Site

Himi, Toyama, Japan

Location

Investigational Site

Kurobe-shi, Toyama, Japan

Location

MeSH Terms

Conditions

PainOsteoarthritis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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

August 1, 2007

Study Completion

August 1, 2007

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations

JP(28)