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NCT05531422
Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With BTcP
Phase 2 trial testing Inhaled fentanyl aerosol in Breakthrough Cancer Pain in 60 participants. Completed in 27 April 2023.
15 March 2023
Quick facts
| Lead sponsor | Lee's Pharmaceutical Limited |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 20 October 2021 |
| Primary completion | 15 March 2023 |
| Estimated completion | 27 April 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Inhaled fentanyl aerosol — full drug profile →
- Placebo
Conditions studied
- Breakthrough Cancer Pain — all drugs for Breakthrough Cancer Pain →
Sponsor
Lee's Pharmaceutical Limited — full company profile →
Who can join
18 and older, any sex, with Breakthrough Cancer Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. This is a phase IIa dose-response and safety study of inhaled fentanyl aerosol (25µg/dose) in Chinese patients with breakthrough cancer pain.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial.
Lin R, Song B, Li N, Rong B, et al · · 2024 · cited 1× · PMID 39244530 · DOI 10.1186/s12904-024-01554-9 -
Efficacy and Safety of Fentanyl Inhalant for the Treatment of Breakthrough Cancer Pain: A Multicenter, Randomized, Double- blind, Placebo-controlled Trial
Lin R, Song B, Li N, Rong B, et al · · 2024 · DOI 10.21203/rs.3.rs-4104172/v1
Verify or expand the search:
- PubMed search for NCT05531422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Inhaled fentanyl aerosol
Trials testing the same drug.
- NCT04713189 — Effectiveness and Tolerance of Inhaled Fentanyl Aerosol (25µg/Dose) in Chinese Patients With Breakthrough Cancer Pain · Phase 1, PHASE2 · unknown
Other Lee's Pharmaceutical Limited trials
Trials by the same sponsor.
- NCT06953453 — A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors · Phase 1 · recruiting
- NCT07099144 — Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension · recruiting
- NCT06459687 — Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer · Phase 3 · recruiting
- NCT06374485 — Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment · Phase 1 · recruiting
- NCT05806918 — Non-inferiority Study of ZK-A03 in Treatment of Herpes Zoster Before and After the Alteration of the Active Ingredient M · Phase 3 · unknown
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 NCT05531422 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lee's Pharmaceutical Limited
- Last refreshed: 12 June 2024
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/NCT05531422.
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