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

September 2, 2014 updated by: International Clinical Research Institute

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • International Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Subsys
Cancer patients experiencing breakthrough pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30, 60, 90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 30, 60, 90 days
Study Medication Ease of Use
Time Frame: Baseline, 30, 60, 90 days
Baseline, 30, 60, 90 days
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.
Baseline, 30, 60, 90 days
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.
Baseline, 30, 60, 90 days
Medication Dosing
Time Frame: Baseline
Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™.
Baseline
Weight
Time Frame: Baseline, 30, 60, 90 days
Baseline, 30, 60, 90 days
Blood Glucose
Time Frame: Baseline and 90 days
Blood will be drawn to measure HbA1c.
Baseline and 90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Optimal Dose Calculation
Time Frame: 14 Days
Time to "optimal" dose of an open-label study medication in the Titration phase.
14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICRI-Subsys-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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