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Placebo for BTDS patch
A placebo patch formulation used as a control comparator in clinical trials for transdermal drug delivery systems.
A placebo patch formulation used as a control comparator in clinical trials for transdermal drug delivery systems. Used for Control comparator in clinical trials (not a therapeutic product).
At a glance
| Generic name | Placebo for BTDS patch |
|---|---|
| Sponsor | Massachusetts General Hospital |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Placebo patches are inert transdermal formulations designed to match the appearance and delivery mechanism of active BTDS (buprenorphine transdermal system) patches while containing no active pharmaceutical ingredient. They serve as the control arm in randomized controlled trials to assess the efficacy and safety of the active drug by isolating pharmacological effects from placebo response and study procedures.
Approved indications
- Control comparator in clinical trials (not a therapeutic product)
Common side effects
Key clinical trials
- Butrans for Treatment of Restless Legs Syndrome (PHASE4)
- The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers (PHASE1)
- Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and Ketoconazole (PHASE1)
- Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee (PHASE3)
- Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain (PHASE3)
- Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain (PHASE3)
- Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement (PHASE2)
- Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension. (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Placebo for BTDS patch CI brief — competitive landscape report
- Placebo for BTDS patch updates RSS · CI watch RSS
- Massachusetts General Hospital portfolio CI