A Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 Compared to Placebo in the Treatment of Cancer Breakthrough Pain

This study has been completed.
Sponsor:
Information provided by:
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00833040
First received: January 28, 2009
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

The purpose of this research study is to evaluate ARX-F02 (Sublingual Sufentanil NanoTab™) versus placebo ("sugar" pill or inactive substance) in the management of breakthrough pain in cancer patients.


Condition Intervention Phase
Cancer
Pain
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Placebo-Controlled, Crossover Study for the Evaluation of the Safety, Tolerability, and Efficacy of ARX-F02 Compared to Placebo in the Treatment of Cancer Breakthrough Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To monitor the safety and tolerability of ARX-F02 during the titration phase, and to assess the safety, tolerability, and efficacy of ARX-F02 compared with placebo during the randomized phase [ Time Frame: 60 minutes after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the difference in pain intensity at 10, 15, 45 and 60 minutes following each dose of study medication [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
7 active, 3 placebo doses taken in Sequence Order 1. Dosage of active determined in titration phase.
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
During the Titration Phase, patients are to titrate to the dose of Sufentanil that provides adequate pain relief without intolerable side effects. Dosages are 20, 30, 40, 60 and 80 mcg. During the Double-Blind Phase, randomized patients will take sufentanil (dosage determined in Titration Phase) and placebo.
2
7 active, 3 placebo doses taken in Sequence Order 2. Dosage of active determined in titration phase.
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
During the Titration Phase, patients are to titrate to the dose of Sufentanil that provides adequate pain relief without intolerable side effects. Dosages are 20, 30, 40, 60 and 80 mcg. During the Double-Blind Phase, randomized patients will take sufentanil (dosage determined in Titration Phase) and placebo.
3
7 active and 3 placebo doses taken in Sequence Order 3. Dosage of active determined in titration phase.
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
During the Titration Phase, patients are to titrate to the dose of Sufentanil that provides adequate pain relief without intolerable side effects. Dosages are 20, 30, 40, 60 and 80 mcg. During the Double-Blind Phase, randomized patients will take sufentanil (dosage determined in Titration Phase) and placebo.
4
7 active, 3 placebo doses taken in Sequence Order 4. Dosage of active determined in titration phase.
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
During the Titration Phase, patients are to titrate to the dose of Sufentanil that provides adequate pain relief without intolerable side effects. Dosages are 20, 30, 40, 60 and 80 mcg. During the Double-Blind Phase, randomized patients will take sufentanil (dosage determined in Titration Phase) and placebo.
5
7 active, 3 placebo doses taken in Sequence Order 5.Dosage of active determined in titration phase.
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
During the Titration Phase, patients are to titrate to the dose of Sufentanil that provides adequate pain relief without intolerable side effects. Dosages are 20, 30, 40, 60 and 80 mcg. During the Double-Blind Phase, randomized patients will take sufentanil (dosage determined in Titration Phase) and placebo.
6
7 active, 3 placebo doses taken in Sequence Order 6. Dosage of active determined in titration phase.
Drug: Sublingual Sufentanil NanoTab (ARX-F02)
During the Titration Phase, patients are to titrate to the dose of Sufentanil that provides adequate pain relief without intolerable side effects. Dosages are 20, 30, 40, 60 and 80 mcg. During the Double-Blind Phase, randomized patients will take sufentanil (dosage determined in Titration Phase) and placebo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years of age or older with documented clinical history or evidence of a malignancy.
  2. Patients must have sufficient pain to require at least the equivalent of 60 mg/day oral morphine, at least 25 mcg/hr transdermal fentanyl, at least 30 mg/day oxycodone, at least 8 mg/day oral hydromorphone for a week or longer.
  3. Patient is experiencing 1 - 4 episodes of cancer breakthrough pain per day, on average but not necessarily every day, requiring use of an additional opioid analgesic.
  4. Patient has a life expectancy of at least 3 months.
  5. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status rating < 2.
  6. Patient must be able to provide reliable documentation of pain intensity, pain relief, use of rescue medication, and global evaluation of treatment personally or with the help of a caregiver.
  7. Patient must be able to enter simple commands on a Palm Pilot device, personally or with the help of a caregiver.
  8. If patient is female and of childbearing potential she must have a negative urine pregnancy test at screening, and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condom, spermicidal foam, 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 1 year or more postmenopausal must be specified in the patient's CRF.
  9. Patient must demonstrate the dexterity to handle the single-dose applicator that will be used for placing the NanoTab™ under the tongue.
  10. Patient and/or caregiver must demonstrate ability to use the NanoTab™ retrieval tool.
  11. There must be a caregiver in the home (or hospice) who will be present for at least 1 hour following each dose during titration.
  12. Patient must provide written informed consent.

Exclusion Criteria:

  1. Patients with uncontrollable or rapidly escalating pain.
  2. Patients with a history of psychiatric disease or loss of cognitive function that would prevent patient from providing reliable study documentation.
  3. Patients with oral mucositis or stomatitis.
  4. Patients with a history of substance abuse within the past year.
  5. Patients who are using intrathecal opioids.
  6. Patients with underlying pulmonary disease such as sleep apnea or chronic obstructive pulmonary disease characterized by CO2 retention that is deemed clinically significant by the investigator.
  7. Patients at risk of significant bradyarrhythmia, in the opinion of the Investigator, due to underlying heart disease.
  8. Patients with abnormal chemistry or hematology that are deemed by the investigator to be clinically significant. Abnormalities that are cancer related should be documented.
  9. Patients with clinically significant abnormality on the Screening ECG who, in the Investigator's opinion, should not participate in the study.
  10. Patients who will be receiving chemotherapy or radiation treatment during the 3-week titration phase or 3-week double-blind phase that, in the Investigator's opinion, may dramatically alter the patient's pain level or response to pain medications.
  11. Patients who are taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
  12. Patients who have participated in a clinical trial of an investigational drug or device within 30 days of screening visit.
  13. Patients who, in the Investigator's opinion, should not participate in the study or may not be capable of following the study schedule or procedures for any reason.
  14. Patients who are employees or family members of the Investigator, study center or AcelRx.
  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: NCT00833040

Locations
United States, California
Clinical Trials and Research Associates
Montebello, California, United States, 90640
United States, Florida
Florida Institute of Medical Research
Jacksonville, Florida, United States, 32257
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Sarasota Pain Medicine Research
Sarasota, Florida, United States, 34238
Lovelace Scientific Resources
Venice, Florida, United States, 34292
United States, Georgia
Drug Studies America, Inc.
Marietta, Georgia, United States, 30060
Better Health Clinical Research, Inc.
Newnan, Georgia, United States, 30265
United States, Kansas
International Clinical Research Institute
Overland Park, Kansas, United States, 66211
United States, Louisiana
Willis-Knighton Pain Management Center
Shreveport, Louisiana, United States, 71103
United States, North Carolina
Four Seasons Hospice & Palliative Care
Flat Rock, North Carolina, United States, 28731
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
United States, Texas
Research Concepts Ltd
Houston, Texas, United States, 77024
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Pamela Palmer, MD, PhD, AcelRx Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00833040     History of Changes
Other Study ID Numbers: ARX-C-003
Study First Received: January 28, 2009
Last Updated: April 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AcelRx Pharmaceuticals, Inc.:
Cancer breakthrough pain

Additional relevant MeSH terms:
Breakthrough 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 23, 2014