Pain, PostoperativePhase 3NCT00666393
An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients
A Phase 3 study testing fentanyl iontophoretic transdermal system (40mcg) in people with Pain, Postoperative and Pediatrics, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Pain, Postoperative, Pediatrics
- What is being tested?
- fentanyl iontophoretic transdermal system (40mcg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2010
- Phase
- Phase 3
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patients must: weigh >= 40 kg
- be scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery
- Be expected by the investigator's staff to require injected opioid analgesia for at least 24 hours after surgery
- Be judged by the investigator's staff to be capable of understanding and cooperating with the requirements of the study.
Who cannot join
- Patients who have undergone any surgery on the airway, head or neck
- Patients who are expected to require intensive care
- Patients who require airway(breathing) support after their surgery
- Patients who received intra-operative (during surgery) and/or post-operative (after surgery) administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil
- Patients with active generalized skin disorders or active local skin disease that precludes the application of fentanyl iontophoretic transdermal system(40 mcg).
About this study
Official title: An Open-Label Evaluation of Safety of the IONSYS System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients
The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.
Read the detailed description
This will be a multicenter, open-label study in which hospitalized pediatric post-operative patients will receive the fentanyl HCl 40 mcg system for up to 3 consecutive days. After their surgery, patients will be brought to the recovery room for initial observation following general or regional anesthesia for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery. Post surgery procedures will be preformed and when analgesia is required, the patient will be titrated to analgesic comfort (a pain score < 4 on a scale 0-10) for at least 30 minutes with an intravenous opioid as clinically appropriate. After a patient has been comfortable (pain intensity of < 4 on 0 -10 color visual analog scale ) for > 30 minutes and has been monitored during recovery and is awake, able to answer questions and follow commands he/she will be assessed for pain intensity, vital signs, and oxygen saturation (amount of oxygen in the blood). If the patient meets study entry criteria, baseline assessments (pain intensity, vital signs, and oxygen saturation) will be completed and the fentanyl HCl 40 mcg system will be applied. During the first 3-hours of the treatment, if a patient successfully completed an on-demand dose and pain relief was still inadequate, the patient could deliver another dose of fentanyl, or be re-titrated to comfort with single or multiple intravenous doses of supplemental opioid medication (IV fentanyl or IV morphine) per study physician's clinical discretion. Supplemental IV doses of opioid medications can be administered in the first 3-hours of system application, but are prohibited after Hour 3. If pain control is judged inadequate with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study. Patients will receive fentanyl HCl 40 mcg system. Fentanyl will be delivered upon patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses whichever occurs first for up to three consecutive days.
- Conditions
- Pain, Postoperative, Pediatrics
- Being tested
- fentanyl iontophoretic transdermal system (40mcg) No placebo, fentanyl iontophoretic transdermal system (40mcg)
- Keywords
- IONSYS™, Pain, Postoperative, Analgesia, Patient-Controlled, Opioids, Pediatrics
- Medical subject headings
- Pain, Postoperative, Agnosia
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; total maximum 80 doses/24 hours
fentanyl iontophoretic transdermal system (40mcg)Drug
40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Not described Receives: Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo; Drug: fentanyl iontophoretic transdermal system (40mcg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.
Measured: Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours.
Secondary outcomes (1)
Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 24.
Measured: Patient, Investigator and Parent Assessments of the treatment will be completed every 24 hours for a maximum of 72 hours. Pharmacokinetic measurements will be completed 4 times during every 24 hours of treatment for a maximum of 12 times over 72 hours.
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 startOct 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Program Cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT00666393
- Sponsor's protocol ID
- CR013048
- Other IDs
- C-2006-007
- Status last verified
- Feb 2014
- First submitted
- 22 Apr 2008
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Evaluation of Safety of the IONSYS System [Fentanyl Iontophoretic Transdermal System (40ug) for Management of Acute Post-Operative Pain in Pediatric Patients
- ClinicalTrials.gov ID
- NCT00666393
- Acronym / sponsor ID
- CR013048
- Conditions
- Pain, Postoperative, Pediatrics
- Keywords
- IONSYS™, Pain, Postoperative, Analgesia, Patient-Controlled, Opioids, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Program Cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- 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 this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.
Detailed description
This will be a multicenter, open-label study in which hospitalized pediatric post-operative patients will receive the fentanyl HCl 40 mcg system for up to 3 consecutive days. After their surgery, patients will be brought to the recovery room for initial observation following general or regional anesthesia for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery. Post surgery procedures will be preformed and when analgesia is required, the patient will be titrated to analgesic comfort (a pain score < 4 on a scale 0-10) for at least 30 minutes with an intravenous opioid as clinically appropriate. After a patient has been comfortable (pain intensity of < 4 on 0 -10 color visual analog scale ) for > 30 minutes and has been monitored during recovery and is awake, able to answer questions and follow commands he/she will be assessed for pain intensity, vital signs, and oxygen saturation (amount of oxygen in the blood). If the patient meets study entry criteria, baseline assessments (pain intensity, vital signs, and oxygen saturation) will be completed and the fentanyl HCl 40 mcg system will be applied. During the first 3-hours of the treatment, if a patient successfully completed an on-demand dose and pain relief was still inadequate, the patient could deliver another dose of fentanyl, or be re-titrated to comfort with single or multiple intravenous doses of supplemental opioid medication (IV fentanyl or IV morphine) per study physician's clinical discretion. Supplemental IV doses of opioid medications can be administered in the first 3-hours of system application, but are prohibited after Hour 3. If pain control is judged inadequate with the combined use of fentanyl HCl 40 mcg system and the use of supplemental analgesia, the patient may be withdrawn from the study. Patients will receive fentanyl HCl 40 mcg system. Fentanyl will be delivered upon patient activation over 10 minutes for a maximum of 6 doses/hour for up to 24 hrs or 80 total doses whichever occurs first for up to three consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: fentanyl iontophoretic transdermal system (40mcg) No placebo, Drug: fentanyl iontophoretic transdermal system (40mcg) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The patients must: weigh >= 40 kg
- be scheduled for abdominal, pelvic/genitourinary, orthopedic, or thoracic surgery
- Be expected by the investigator's staff to require injected opioid analgesia for at least 24 hours after surgery
- Be judged by the investigator's staff to be capable of understanding and cooperating with the requirements of the study.
Key exclusion criteria (5 listed)
- Patients who have undergone any surgery on the airway, head or neck
- Patients who are expected to require intensive care
- Patients who require airway(breathing) support after their surgery
- Patients who received intra-operative (during surgery) and/or post-operative (after surgery) administration of opioids other than morphine, hydromorphone, fentanyl, sufentanil or alfentanil
- Patients with active generalized skin disorders or active local skin disease that precludes the application of fentanyl iontophoretic transdermal system(40 mcg).
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; total maximum 80 doses/24 hours | Drug | 001 |
| fentanyl iontophoretic transdermal system (40mcg)40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours | Drug | 001 |
Primary outcome
Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter.
Time frame: Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours.
1 secondary outcome
Patient Global Assessment, Investigator Global Assessment and Parent Assessment of Patient Use will be completed every 24 hours. Serum fentanyl concentration will be collected at Hours 3, 6,12, and 24.
Time frame: Patient, Investigator and Parent Assessments of the treatment will be completed every 24 hours for a maximum of 72 hours. Pharmacokinetic measurements will be completed 4 times during every 24 hours of treatment for a maximum of 12 times over 72 hours.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fentanyl iontophoretic transdermal system (40mcg) in people with Pain, Postoperative and Pediatrics, run by Alza Corporation, DE, USA.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Any adverse events will be recorded. Oxygen saturation will be monitored continuously. Vital signs (BP, HR, RR, T), oxygen saturation, and concomitant medications will be recorded at Hours 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and every 4 hours thereafter. (time frame: Safety outcomes will be collected at intervals throughout the drug system application for a maximum of 72 hours.). 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 3 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.