A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00894699
First received: May 5, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).


Condition Intervention Phase
Sedation
Anxiety
Pain
Drug: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)
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
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTabs™ in Patients Undergoing an Elective Abdominal Liposuction Procedure

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4) [ Time Frame: 4 hour study period ] [ Designated as safety issue: Yes ]
    The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.


Enrollment: 40
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
Drug: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)
Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
Placebo Comparator: 2
single dose of sublingual Placebo NanoTab™
Drug: Placebo NanoTab™
Single dose of sublingual placebo NanoTab™

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must have provided written informed consent to participate in the study.
  2. Male or female patient between 18 to 60 (inclusive) years of age.
  3. Patient is planning to undergo an elective outpatient abdominal liposuction procedure.
  4. Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
  5. Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 20 and 35, inclusively.
  6. Female patients of childbearing potential must be using an effective method of birth control at the time of the screening visit and for 30 days following the dosing of study medication. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified. Patients using hormonal forms of contraception must also be willing to use a barrier method of contraception from screening through 30 days following the dose of study medication.
  7. Patient is willing to receive antibiotics as per the normal practice of the surgeon.
  8. Patient understands that preoperative analgesics or anxiolytics are not permitted.
  9. Patient is willing to avoid caffeine and alcohol use within 24 hours before the procedure.
  10. The patient must be willing and able to understand the study procedures and the use of pain and anxiety scales, and to communicate meaningfully with the study personnel.
  11. The patient must have a caregiver available to escort the patient home following the procedure.

Exclusion Criteria:

  1. Patient who is expected to require less than 400 cc or more than 700 cc of abdominal fat removal during the procedure.
  2. Patient has previously not responded to opioid analgesics for treatment of pain.
  3. Patient has previously not responded to benzodiazepines for treatment of anxiety.
  4. Patient is currently taking any opioid or has taken any opioid for more than 7 consecutive days of daily use within the past 3 months prior to the procedure.
  5. Patient is currently taking any benzodiazepine or has taken any benzodiazepine for more than 7 consecutive days within the past 3 months prior to the procedure.
  6. Patient is taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
  7. Patient has an allergy or hypersensitivity to opioids.
  8. Patient who is currently taking anti-inflammatory drugs, including steroids.
  9. Use of drugs which are P450 3A4 inducers or inhibitors within 30 days of dosing including alprazolam, chlorpheniramine, cimetidine, fluoxetine, haloperidol, ketoconazole, itraconazole, erythromycin, clarithromycin, sildenafil, simvastatin, St. John's Wort.
  10. Patient who is taking calcium channel blockers or beta blockers.
  11. Patient who will consume grapefruit, or products made with grapefruit, within 3 days of study medication dosing.
  12. Patient with a history of chronic obstructive pulmonary disease (COPD) or any other respiratory condition or active pulmonary disease.
  13. Patient currently has sleep apnea that has been documented by a sleep laboratory study.
  14. Patient is a woman who is pregnant or lactating.
  15. Patient has a history of an anxiety disorder.
  16. Patients with oral mucositis or stomatitis.
  17. Patient has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
  18. Patient used an investigational drug or device within 30 days of screening visit.
  19. Patient has undergone a liposuction procedure previously.
  20. Patient has a history of migraine or chronic headache.
  21. Patient who has a positive urine screen for drugs of abuse at screening or on the day of procedure.
  22. Patient who has a positive alcohol screen on the day of the procedure.
  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: NCT00894699

Locations
United States, California
Lotus Clinical Research, Inc.
Pasadena, California, United States, 91105
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Study Director: Pamela Palmer, M.D., PhD AcelRx Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00894699     History of Changes
Other Study ID Numbers: ARX-C-007
Study First Received: May 5, 2009
Results First Received: January 10, 2014
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AcelRx Pharmaceuticals, Inc.:
procedural sedation

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Triazolam
Sufentanil
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 20, 2014