# A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement

> **NCT00612534** · PHASE2 · COMPLETED · sponsor: **Talphera, Inc** · enrollment: 94 (actual)

## Conditions studied

- Post Operative Pain

## Interventions

- **DRUG:** Sufentanil NanoTab
- **DRUG:** Placebo NanoTab
- **DRUG:** Sufentanil NanoTab
- **DRUG:** Sufentanil NanoTab

## Key facts

- **NCT ID:** NCT00612534
- **Lead sponsor:** Talphera, Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2008-03
- **Primary completion:** 2008-10
- **Final completion:** 2008-10
- **Target enrollment:** 94 (ACTUAL)
- **Last updated:** 2014-02-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00612534

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00612534, "A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT00612534. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*