Last reviewed · How we verify
NCT01539538
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
Phase 3 trial testing Sufentanil NanoTab PCA System/15 mcg in Post-Operative Pain in 357 participants. Completed in 1 December 2012.
1 December 2012
Quick facts
| Lead sponsor | Talphera, Inc |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 357 |
| Start date | 1 April 2012 |
| Primary completion | 1 December 2012 |
| Estimated completion | 1 December 2012 |
| Sites | 16 locations across United States |
Drugs / interventions tested
- Sufentanil NanoTab PCA System/15 mcg — full drug profile →
- morphine IV PCA — full drug profile →
Conditions studied
- Post-Operative Pain — all drugs for Post-Operative Pain →
Sponsor
Talphera, Inc — full company profile →
Who can join
18 and older, any sex, with Post-Operative Pain. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Patient Global Satisfaction
Time frame: 48 hours
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Sponsor's own description
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial.
Melson TI, Boyer DL, Minkowitz HS, Turan A, et al · · 2014 · cited 55× · PMID 25155134 · DOI 10.1111/papr.12238 -
Evolution of Patient-Controlled Analgesia: From Intravenous to Sublingual Treatment.
Golembiewski J, Dasta J, Palmer PP. · · 2016 · cited 3× · PMID 38745577 · DOI 10.1310/hpj5103-214
Verify or expand the search:
- PubMed search for NCT01539538
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Post-Operative Pain
Currently open trials in the same condition.
- NCT06991231 — The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty · NA · recruiting
Other Talphera, Inc trials
Trials by the same sponsor.
- NCT02662764 — Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg · 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 NCT01539538 (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 Talphera, Inc
- Last refreshed: 16 September 2015
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/NCT01539538.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing