Last reviewed · How we verify
NCT01416116: LIFT
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
Phase 4 trial testing QUTENZA in or Peripheral Nerve Injury (PNI) in 122 participants. Completed in 25 April 2012.
25 April 2012
Quick facts
| Lead sponsor | Astellas Pharma Inc |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 122 |
| Start date | 6 July 2011 |
| Primary completion | 25 April 2012 |
| Estimated completion | 25 April 2012 |
| Sites | 20 locations across Denmark, Slovakia, Belgium, Ireland, United Kingdom, Norway, Czechia |
Drugs / interventions tested
- QUTENZA (CAPSAICIN) — full drug profile →
- Lidocaine — full drug profile →
- Tramadol (tramadol) — full drug profile →
Conditions studied
- or Peripheral Nerve Injury (PNI) — all drugs for or Peripheral Nerve Injury (PNI) →
- Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) — all drugs for Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) →
Sponsor
Astellas Pharma Inc — full company profile →
Who can join
Adults 18 to 90, any sex, with or Peripheral Nerve Injury (PNI) or Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01416116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of QUTENZA
Trials testing the same drug.
- NCT01252160 — Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage · Phase 4 · completed
Other Astellas Pharma Inc trials
Trials by the same sponsor.
- NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
- NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
- NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
- NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
- NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · 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 NCT01416116 (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 Astellas Pharma Inc
- Last refreshed: 23 April 2018
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/NCT01416116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing