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An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.

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ClinicalTrials.gov Identifier: NCT01901718
Recruitment Status : Terminated (Enrollment was more challenging than anticipated.)
First Posted : July 17, 2013
Last Update Posted : September 4, 2014
Information provided by (Responsible Party):
International Clinical Research Institute

Brief Summary:
Chronic pain patients who experience breakthrough pain in the background of controlled persistent pain with opioids will be followed for 3 months in order to assess the safety and titration trends in the clinical practice setting of a novel fentanyl sublingual spray (Subsys™) for the treatment of breakthrough pain.

Condition or disease
Breakthrough Pain

Detailed Description:
Approximately 100 subjects across 10 centers throughout the United States will be enrolled into the study. Subjects who are currently taking Actiq® for their breakthrough pain and will be discontinued due to lack of efficacy, poor tolerability, patient or prescriber dissatisfaction and meet all other study inclusion criteria and none of the exclusion criteria will be candidates to receive a sublingual fentanyl spray (Subsys™). The total duration of the study for each subject will be no more than 4 months.

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray Compared to Actiq® for the Management of Breakthrough Pain in Chronic Pain Patients.
Study Start Date : April 2013
Primary Completion Date : December 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Cancer patients experiencing breakthrough pain.

Primary Outcome Measures :
  1. Patient Global Impression of Change [ Time Frame: 30, 60, 90 days ]
    The overall impression of change based on a patient's response to the Patient Global Impression of Change (PGIC) questionnaire at month 1, 2, and 3 or upon early discontinuation.

Secondary Outcome Measures :
  1. Percent of Patients Satisfied with Treatment [ Time Frame: Baseline, 30, 60, 90 days ]
    Patients will rate their treatment satisfaction using a 5-point scale ranging from 1= Very Dissatisfied to 5= Very Satisfied.

  2. Study Medication Ease of Use [ Time Frame: Baseline, 30, 60, 90 days ]
  3. Quality of Life [ Time Frame: Baseline, 30, 60, 90 days ]
    Short Form 12 Question Health Survey Version 2 (SF-12v2) will be used to assess a subject's general quality of life.

  4. Assessment of Sleep [ Time Frame: Baseline, 30, 60, 90 days ]
    Medical Outcomes Score (MOS) Sleep Subscale will be used to measures 6 dimensions of sleep and is a useful indicator of the efficacy of analgesic medications.

  5. Medication Dosing [ Time Frame: Baseline ]
    Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™.

  6. Weight [ Time Frame: Baseline, 30, 60, 90 days ]
  7. Blood Glucose [ Time Frame: Baseline and 90 days ]
    Blood will be drawn to measure HbA1c.

Other Outcome Measures:
  1. Optimal Dose Calculation [ Time Frame: 14 Days ]
    Time to "optimal" dose of an open-label study medication in the Titration phase.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic pain patients who are opioid tolerant and who have failed Actiq® therapy for their breathrough pain will be prescribed Subsys™ fentanyl sublingual spray for their breakthrough pain.

Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • Subjects who are experiencing 1-4 episodes of break through pain per day in spite of optimized background analgesia and who have taken at least 60 mg/day of morphine (or equivalent analgesic) for at least 7 days.
  • Who are currently using Actiq® for their breakthrough pain and are being discontinued due to lack of efficacy, side effects, patient dissatisfaction or prescriber dissatisfaction with treatment.
  • Are able to follow and complete all necessary study procedures.
  • Are willing and able to give written informed consent before participating in the study.
  • Enrolled in the class wide REMS as verified by the study personnel.

Exclusion Criteria:

  • Subjects who are not opioid tolerant.
  • Using a rapid onset opioid other than Actiq® to manage their breakthrough pain.
  • Have physical abnormalities of the floor of the mouth that could affect absorption as determined by investigator.
  • Are subjects with uncontrolled or rapidly escalating pain.
  • Are subjects with a history of alcohol or substance abuse within the last 3 years.
  • Have a clinically significant medical history (past or present) of any disease that would compromise the study or the well-being of the subject.
  • Are subjects who have participated in another clinical trial with an analgesic within the last month.
  • Are female subjects with a positive pregnancy test or who are currently lactating.
  • Are subjects who are taking medications that are known inhibitors of the CYP3A4 isozyme, such as ketoconazole.
  • Are subjects who have taken a monoamine inhibitor within 14 days before a dose of study medication.
  • Opioid being used for chronic migraine or acute pain.
  • Are subjects who are unsuitable for inclusion for any other reason, in the opinion of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901718

United States, Kansas
International Clinical Research Institute
Overland Park, Kansas, United States, 66210
Sponsors and Collaborators
International Clinical Research Institute
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute

Responsible Party: International Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01901718     History of Changes
Other Study ID Numbers: ICRI-Subsys-001
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

Keywords provided by International Clinical Research Institute:
Breakthrough Pain
Persistent Pain

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