PainNCT00665522
A Prospective Safety Surveillance Study of Fentanyl Iontophoretic Transdermal System (40 Mcg)
An observational study of Pain, run by Alza Corporation, DE, USA at 26 sites in 4 countries.
Trial summary
The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 26 sitesin 4 countries
- Study dates
- Dec 2007to Sep 2008
- 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: Approximately 3,000 patients who have scheduled surgery and need treatment of acute moderate to severe post-operative pain and are treated with fentanyl HCl 40 mcg system in the hospital setting will be evaluated. In addition, a group of approximately 1,500 patients treated with opioid intravenous patient-controlled analgesia (IV PCA) will be matched to fentanyl HCl 40 mcg system patients with respect to (1) country (match will first be sought within the same research center, and extended to patients in the same country if no match is found), (2) pre-surgical physical condition and (3) surgery risk (high risk versus low risk). Patients at multiple research centers in multiple countries will be included.
Who may be able to join
- Adult patients
- Planned surgery
- Planned use of fentanyl HCl 40 mcg system or IV Patient-Controlled Analgesia opioid treatment for postoperative pain
Who cannot join
- Pain resulting from emergency surgery
Trial locations and contacts
26 sites in 4 countries.
26 sites in 4 countries
Germany15 sites
Study site
Aachen
Study site
Bad Dürkheim
Study site
Bergisch Gladbach
Study site
Berlin
Study site
Bonn
Study site
Cologne
Study site
Hamburg
Study site
Hanover
Study site
Kaiserslautern
Study site
Koblenz
Study site
München
Study site
Neubrandenburg
Study site
Sinsheim
Study site
Speyer
Study site
Wÿrzburg
Austria8 sites
Study site
Feldkirch
Study site
Graz
Study site
Klagenfurt
Study site
Linz
Study site
Salzburg
Study site
Vienna
Study site
Wels
Study site
Wiener Neustadt
About this study
Official title: A Prospective Safety Surveillance Study of IONSYS (Fentanyl HCl)
The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.
Read the detailed description
The safety of fentanyl HCl 40 mcg system has been evaluated in a number of research studies. Although this research included patients with acute moderate to severe pain after particular types of surgery, including abdominal, pelvic, and orthopedic procedures, the safety associated with use under conditions of routine post-operative clinical care may not have been completely characterized by the study database. This study will be a surveillance study on the risks associated with the usage of fentanyl HCl 40 mcg system under such conditions. Approximately 3,000 patients who have scheduled surgery and need treatment of acute moderate to severe post-operative pain and are treated with fentanyl HCl 40 mcg system in the hospital setting will be evaluated. In addition, a group of approximately 1,500 patients treated with opioid intravenous patient-controlled analgesia (IV PCA) will be matched to fentanyl HCl 40 mcg system patients with respect to (1) country (match will first be sought within the same research center, and extended to patients in the same country if no match is found), (2) pre-surgical physical condition and (3) surgery risk (high risk versus low risk). Patients at multiple research centers in multiple countries will be included. Patients with planned surgery and anticipated use of opioid pain management for post-operative care who are candidates for treatment with fentanyl HCl 40 mcg system or IV PCA opioid treatment will have the study explained and may participate after giving informed consent if they meet the study entry criteria. Enrollment in the study begins prior to their surgical procedure. Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation. Data collection in this observational (non-interventional) study will begin after informed consent is obtained and admission to the study center for the surgical procedure and will continue until discontinuation of fentanyl HCl 40 mcg system or IV PCA opioid treatment. Any significant changes in medical condition will be followed until they have resolved or have become medically stable. Patients will receive fentanyl iontophoretic transdermal system 40 mcg (fentanyl HCl 40 mcg delivered by patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses) or Intravenous Patient-Controlled Analgesia (IV PCA) opioid (medication choice, treatment regimen, and operation of the PCA pump to be consistent with standard practice at participating centers). Treatment duration to be determined by the treating physician.
- Conditions
- Pain
- Being tested
- fentanyl iontophoretic transdermal system (40mcg) No Placebo, IV PCA with standard of care opioid analgesia
- Keywords
- Pain, Postoperative Analgesia, Patient-Controlled Opioids
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl iontophoretic transdermal system (40mcg) No PlaceboDrug
40 mcg per dose, maximum of 6 doses/hour
IV PCA with standard of care opioid analgesiaDrug
total maximum 80 doses/24 hours
| Study group | Role | What they receive |
|---|---|---|
| 001 | fentanyl iontophoretic transdermal system (40mcg) No Placebo 40 mcg per dose maximum of 6 doses/hourtotal maximum 80 doses/24 hours Receives: Drug: fentanyl iontophoretic transdermal system (40mcg) No Placebo | |
| 002 | IV PCA with standard of care opioid analgesia per 24 hour period Receives: Drug: IV PCA with standard of care opioid analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.
Measured: Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study was terminated at the request of the company due to the recall of marketed product in Europe.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665522
- Sponsor's protocol ID
- CR013201
- Other IDs
- C-2006-001
- Status last verified
- Apr 2015
- First submitted
- 22 Apr 2008
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Safety Surveillance Study of IONSYS (Fentanyl HCl)
- ClinicalTrials.gov ID
- NCT00665522
- Acronym / sponsor ID
- CR013201
- Conditions
- Pain
- Keywords
- Pain, Postoperative Analgesia, Patient-Controlled Opioids
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated at the request of the company due to the recall of marketed product in Europe.
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Apr 2008 (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.
The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.
Detailed description
The safety of fentanyl HCl 40 mcg system has been evaluated in a number of research studies. Although this research included patients with acute moderate to severe pain after particular types of surgery, including abdominal, pelvic, and orthopedic procedures, the safety associated with use under conditions of routine post-operative clinical care may not have been completely characterized by the study database. This study will be a surveillance study on the risks associated with the usage of fentanyl HCl 40 mcg system under such conditions. Approximately 3,000 patients who have scheduled surgery and need treatment of acute moderate to severe post-operative pain and are treated with fentanyl HCl 40 mcg system in the hospital setting will be evaluated. In addition, a group of approximately 1,500 patients treated with opioid intravenous patient-controlled analgesia (IV PCA) will be matched to fentanyl HCl 40 mcg system patients with respect to (1) country (match will first be sought within the same research center, and extended to patients in the same country if no match is found), (2) pre-surgical physical condition and (3) surgery risk (high risk versus low risk). Patients at multiple research centers in multiple countries will be included. Patients with planned surgery and anticipated use of opioid pain management for post-operative care who are candidates for treatment with fentanyl HCl 40 mcg system or IV PCA opioid treatment will have the study explained and may participate after giving informed consent if they meet the study entry criteria. Enrollment in the study begins prior to their surgical procedure. Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation. Data collection in this observational (non-interventional) study will begin after informed consent is obtained and admission to the study center for the surgical procedure and will continue until discontinuation of fentanyl HCl 40 mcg system or IV PCA opioid treatment. Any significant changes in medical condition will be followed until they have resolved or have become medically stable. Patients will receive fentanyl iontophoretic transdermal system 40 mcg (fentanyl HCl 40 mcg delivered by patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses) or Intravenous Patient-Controlled Analgesia (IV PCA) opioid (medication choice, treatment regimen, and operation of the PCA pump to be consistent with standard practice at participating centers). Treatment duration to be determined by the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: fentanyl iontophoretic transdermal system (40mcg) No Placebofentanyl iontophoretic transdermal system (40mcg) No Placebo 40 mcg per dose maximum of 6 doses/hourtotal maximum 80 doses/24 hours |
| 002 | – | Drug: IV PCA with standard of care opioid analgesiaIV PCA with standard of care opioid analgesia per 24 hour period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 3,000 patients who have scheduled surgery and need treatment of acute moderate to severe post-operative pain and are treated with fentanyl HCl 40 mcg system in the hospital setting will be evaluated. In addition, a group of approximately 1,500 patients treated with opioid intravenous patient-controlled analgesia (IV PCA) will be matched to fentanyl HCl 40 mcg system patients with respect to (1) country (match will first be sought within the same research center, and extended to patients in the same country if no match is found), (2) pre-surgical physical condition and (3) surgery risk (high risk versus low risk). Patients at multiple research centers in multiple countries will be included.
Key inclusion criteria (3 listed)
- Adult patients
- Planned surgery
- Planned use of fentanyl HCl 40 mcg system or IV Patient-Controlled Analgesia opioid treatment for postoperative pain
Key exclusion criteria (1 listed)
- Pain resulting from emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl iontophoretic transdermal system (40mcg) No Placebo40 mcg per dose, maximum of 6 doses/hour | Drug | 001 |
| IV PCA with standard of care opioid analgesiatotal maximum 80 doses/24 hours | Drug | 002 |
Primary outcome
The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported.
Time frame: Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation.
Results and safety
The study was stopped early (reason given: Study was terminated at the request of the company due to the recall of marketed product in Europe.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- A Prospective Safety Surveillance Study of IONSYS (Fentanyl HCl)Link provided by the sponsor.
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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.
Alza Corporation Clinical Trial study director
ALZA
26 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Alza Corporation, DE, USA at 26 sites in 4 countries.
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 3 inclusion and 1 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 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Austria, Finland, Netherlands. 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: Study was terminated at the request of the company due to the recall of marketed product in Europe.). 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?
The purpose of the study is to document the use of fentanyl HCl 40 mcg system under routine conditions and obtain a more comprehensive understanding of the safety of the system and complications that may not be spontaneously reported. (time frame: Patients will receive treatment and care according to the standard practices at the study center, including: treatment choice, pain management set-up, and operation.). 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 10 Apr 2015.