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NCT03967327
A Study to Evaluate Buprenorphine Transdermal Patch in Chinese Subjects With Moderate to Severe Chronic Cancer Pain
Phase 3 trial testing Buprenorphine transdermal patches in Cancer Pain in 194 participants. Status unknown.
20 December 2020
Quick facts
| Lead sponsor | Mundipharma (China) Pharmaceutical Co. Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 194 |
| Start date | 22 April 2019 |
| Primary completion | 20 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Buprenorphine transdermal patches — full drug profile →
- Morphine Sulfate Sustained-Release Tablet — full drug profile →
Conditions studied
- Cancer Pain — all drugs for Cancer Pain →
Sponsor
Mundipharma (China) Pharmaceutical Co. Ltd — full company profile →
Who can join
18 and older, any sex, with Cancer Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomised, active-controlled, double-blind, double-dummy, parallel group study with BUP TDS 20 mg (release rate 35 µg/h), 30 mg (release rate 52.5 µg/h) and 40 mg (release rate 70 µg/h), and MOR SR 60 mg, 100 mg or 120 mg per day. The study consists of 3 phases: a Pre-randomisation Phase, a Double-blind Phase and a Safety Follow-up Phase. There will be 194 subjects to be randomized, with 97 randomized subjects in each arm to ensure 154 evaluable (per protocol population) subjects in the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03967327
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Mundipharma (China) Pharmaceutical Co. Ltd trials
Trials by the same sponsor.
- NCT03975010 — Buprenorphine Transdermal Patches Pharmacokinetic Study · Phase 1 · unknown
- NCT03398278 — OTR Tablet 40 mg Fasted-state Bioequivalence Study · Phase 1 · completed
- NCT03387241 — Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years · Phase 3 · unknown
- NCT03398330 — OTR Tablet 40 mg Fed-state Bioequivalence Study · Phase 1 · completed
- NCT03403504 — OTR Tablet 10 mg Fasted-state Bioequivalence Study · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03967327 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mundipharma (China) Pharmaceutical Co. Ltd
- Last refreshed: 11 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03967327.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing