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

NCT01901718 | Terminated

• 1 other identifier: ICRI-Subsys-001
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Breakthrough Pain

Keywords

Breakthrough Pain; Subsys; Fentanyl; Opioid; Persistent Pain

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change

  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.

  30, 60, 90 days

Secondary Outcomes (7)

• Percent of Patients Satisfied with Treatment

  Baseline, 30, 60, 90 days

• Study Medication Ease of Use

  Baseline, 30, 60, 90 days

• Quality of Life

  Baseline, 30, 60, 90 days

• Assessment of Sleep

  Baseline, 30, 60, 90 days

• Medication Dosing

  Baseline

Other Outcomes (1)

• Optimal Dose Calculation

  14 Days

Study Arms (1)

Subsys

Cancer patients experiencing breakthrough pain.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Clinical Research Institute: lead

Study Sites (1)

International Clinical Research Institute

Overland Park, Kansas, 66210, United States

Location

MeSH Terms

Conditions

Breakthrough Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Srinivas Nalamachu, MD

  International Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: July 17, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

US (1)