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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: January 23, 2015
Last verified: January 2015
  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: Sufentanil NanoTab 20 mcg
Drug: Sufentanil NanoTab 30 mcg
Drug: Placebo NanoTab
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:
  • SPID-12 [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

    The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.

    The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.



Enrollment: 101
Study Start Date: October 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
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
Drug: Sufentanil NanoTab 20 mcg
Experimental: Sufentanil NanoTab 30 mcg
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
Drug: Sufentanil NanoTab 30 mcg
Placebo Comparator: Placebo NanoTab
Placebo NanoTab as needed every 60 minutes for 12 hours
Drug: Placebo NanoTab

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01710345     History of Changes
Other Study ID Numbers: SAP202 
Study First Received: October 17, 2012
Results First Received: December 15, 2014
Last Updated: January 23, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016