Breakthrough PainNCT01901718
An Observational, Non-Interventional Trial to Assess Patient Satisfaction and Safety of Subsys™ Spray.
An observational study of Breakthrough Pain, run by International Clinical Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Pain
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
International Clinical Research Institute
Overland Park, Kansas, 66210
About this study
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.
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.
Read the 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.
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough Pain, Subsys, Fentanyl, Opioid, Persistent Pain
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subsys | Cancer patients experiencing breakthrough pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30, 60, 90 days
Secondary outcomes (7)
Percent of Patients Satisfied with Treatment
Patients will rate their treatment satisfaction using a 5-point scale ranging from 1= Very Dissatisfied to 5= Very Satisfied.
Measured: Baseline, 30, 60, 90 days
Study Medication Ease of Use
Measured: Baseline, 30, 60, 90 days
Quality of Life
Short Form 12 Question Health Survey Version 2 (SF-12v2) will be used to assess a subject's general quality of life.
Measured: Baseline, 30, 60, 90 days
Assessment of Sleep
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.
Measured: Baseline, 30, 60, 90 days
Medication Dosing
Equianalgesic dosing will be calculated based on subject's prior dose of Actiq® and final effective dose of Subsys™.
Measured: Baseline
Weight
Measured: Baseline, 30, 60, 90 days
Blood Glucose
Blood will be drawn to measure HbA1c.
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Why it stopped: Enrollment was more challenging than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Clinical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Srinivas Nalamachu, MD, Principal investigator, International Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901718
- Sponsor's protocol ID
- ICRI-Subsys-001
- Status last verified
- Sep 2014
- First submitted
- 25 Apr 2013
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01901718
- Acronym / sponsor ID
- ICRI-Subsys-001
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough Pain, Subsys, Fentanyl, Opioid, Persistent Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment was more challenging than anticipated.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- International Clinical Research InstituteUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subsys | – | –Cancer patients experiencing breakthrough pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Percent of Patients Satisfied with Treatment
Time frame: Baseline, 30, 60, 90 days
Study Medication Ease of Use
Time frame: Baseline, 30, 60, 90 days
Quality of Life
Time frame: Baseline, 30, 60, 90 days
Assessment of Sleep
Time frame: Baseline, 30, 60, 90 days
Medication Dosing
Time frame: Baseline
Weight
Time frame: Baseline, 30, 60, 90 days
Blood Glucose
Time frame: Baseline and 90 days
Results and safety
The study was stopped early (reason given: Enrollment was more challenging than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas Nalamachu, MD principal investigator
International Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Pain, run by International Clinical Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment was more challenging than anticipated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Change (time frame: 30, 60, 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.