Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00313833
• Date of registration: 10/04/2006
• Primary sponsor: Purdue Pharma LP
• Public title: Safety and Effectiveness of Buprenorphine Transdermal System in Elderly Subjects With Chronic Pain: Pilot Study.
• Scientific title: A Randomized, Double Blind, Pilot Evaluation of the Effectiveness of BTDS Versus Placebo on Health Outcomes Associated With Analgesic Management of Elderly Residents in Supervised Living Environments
• Date of first enrolment: December 2000
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00313833
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- residing in a nursing home, assisted living environment, or any type of supervised
living situation in which the principal investigator maintained primary
responsibility for the analgesic management of the resident.

- chronic pain of musculoskeletal origin who had been managed with short-acting
opioids.

Exclusion Criteria:

- taking >90 mg oral morphine sulfate per day (during any single day) or >50 mcg/hr of
transdermal fentanyl or its equivalent.

- activity restricted totally to bed rest.

- have cancer-related pain.

Other protocol-specific exclusion/inclusion criteria may apply.



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Pain

Intervention(s)

Drug: Buprenorphine transdermal delivery system

Primary Outcome(s)

Pilot study.

Secondary Outcome(s)

acceptability of analgesic therapy

and use of medications for the treatment of drug-related adverse events.

average pain intensity in the last 24 hours

bowel status during the last 24 hours

digit span test

end of study global evaluation of therapeutic response

examination and geriatric depression scale.

Health Assessment Questionnaire

modified mini-mental state

number of nighttime awakenings due to pain last night

number of phone calls to physicians for pain management

number of physician visits for pain management

pain management evaluation

quality of sleep

resident-defined activity impairment scale

staff evaluation of functional independence

symptom evaluation

The following measures of health resource utilization were assessed:

The following outcome variables were assessed:

Timed "Up & Go" evaluation

trail making test

treatment satisfaction questionnaire

use of analgesic medications (usual care plus BTDS) by medication and dosage form

use of analgesic medications (usual care plus BTDS) by product type

use of pain-related adjuvant medications by product type

Secondary ID(s)

BUP3002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors