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Completed

NCT Number: NCT00313833

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

This pilot study was designed to evaluate the effectiveness and tolerability of the buprenorphine transdermal system versus placebo on health outcomes in elderly residents in supervised living environments. The treatment intervention duration is 42 days during which time supplemental analgesic medication (usual analgesic care) will be provided to all subjects in addition to study drug.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Birmingham Health Center, Birmingham, Alabama, United States

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About this study

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buprenorphine transdermal delivery system

Drug

Primary outcomes

  1. Pilot study.

Secondary outcomes

  1. The following outcome variables were assessed:

  2. average pain intensity in the last 24 hours

  3. acceptability of analgesic therapy

  4. number of nighttime awakenings due to pain last night

  5. quality of sleep

  6. bowel status during the last 24 hours

  7. pain management evaluation

  8. symptom evaluation

  9. staff evaluation of functional independence

  10. resident-defined activity impairment scale

  11. treatment satisfaction questionnaire

  12. Health Assessment Questionnaire

  13. Timed "Up & Go" evaluation

  14. trail making test

  15. digit span test

  16. end of study global evaluation of therapeutic response

  17. modified mini-mental state

  18. examination and geriatric depression scale.

  19. The following measures of health resource utilization were assessed:

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

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

  22. use of pain-related adjuvant medications by product type

  23. number of phone calls to physicians for pain management

  24. number of physician visits for pain management

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

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Registry information

Official study 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

Important dates

Study start
2000
Study completion
2001
First posted
Apr 12, 2006
Registry last updated
May 3, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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