Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01710345
First received: October 17, 2012
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.


Condition Intervention Phase
Acute Pain
Drug: Sublingual sufentanil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AcelRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Time Weighted Summed Pain Intensity Difference

Enrollment: 101
Study Start Date: November 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sufentanil NanoTab 20 mcg Drug: Sublingual sufentanil
Experimental: Sufentanil NanoTab 30 mcg Drug: Sublingual sufentanil
Placebo Comparator: Placebo NanoTab

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients scheduled for bunion surgery

Exclusion Criteria:

  • daily opioid use
  • drug or alcohol abuse
  • pregnant or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710345

Locations
United States, California
Lotus Clinical Research
Pasadena, California, United States
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01710345     History of Changes
Other Study ID Numbers: SAP202
Study First Received: October 17, 2012
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014