# Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain

> **NCT00538863** · PHASE3 · COMPLETED · sponsor: **INSYS Therapeutics Inc** · enrollment: 319 (actual)

## Conditions studied

- Cancer
- Pain

## Interventions

- **DRUG:** Fentanyl sublingual spray

## Key facts

- **NCT ID:** NCT00538863
- **Lead sponsor:** INSYS Therapeutics Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2007-12
- **Primary completion:** 2010-10
- **Final completion:** 2010-10
- **Target enrollment:** 319 (ACTUAL)
- **Last updated:** 2013-10-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00538863

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00538863, "Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT00538863. Licensed CC0.

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