Chronic PainPhase 2NCT00943566
A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer
A Phase 2 study testing Sufentanil and Sustained Release Morphine Sulfate in people with Chronic Pain, run by Labtec GmbH.
Trial summary
The study hypothesis is that the safety and efficacy of sufentanil following transdermal application is comparable to sustained release morphine sulphate tablets in patients with chronic pain due to cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Sufentanil and Sustained Release Morphine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Feb 2011
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 75 with a diagnosis of cancer;
- If female, is non-pregnant (negative pregnancy test at Visit 1) and non-lactating;
- If female, is not of childbearing potential
- Documented history of moderate to severe chronic cancer pain requiring around-the-clock therapy and are likely to benefit from WHO step III opioid analgesics for the duration of the study;
- Has been informed of the nature of the study and has provided written informed consent;
- Is willing, able, and competent to complete the entire study and comply with study instructions
Who cannot join
- Patient is a pregnant or lactating female (serum pregnancy test conducted at the Screening Visit);
- Any ongoing serious adverse events (SAEs) at screening and at baseline;
- Has scheduled elective surgery or other invasive procedures during the period of study participation;
- Patients with a known intolerance to opioid analgesics or any excipient of the Investigational Product;
- Patients with respiratory depression with hypoxia and/or hypercapnia, sever chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus, (obstructive) sleep apnea syndrome;
- Evidence of clinically significant cardiovascular, renal, hepatic or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the results;
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- Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (> 3 times the upper level of normal) or an abnormal total bilirubin level (> 1.5 times the upper level of normal) or creatinine clearance < 50 ml/min (calculated using the Cockcroft-Gault formula);
- Patients with uncontrolled seizures;
- Patients with increased intracranial pressure;
- Patients who are receiving hypnotics or other central nervous system (CNS) depressants that, in the opinion of the investigator, may pose a risk of additional CNS depression with opioid medication;
- Patients with myxoedema, inadequately controlled hypothyroidism or Addisons disease;
- History of alcohol and/or drug abuse (or a positive urine drug screen at Visit 1) within one year preceding the Screening Visit;
- Active skin disease;
- Patients suffering from diarrhea and/or opioid withdrawal;
- Known positive Hepatitis B or C or HIV status;
- Has participated in another clinical study of drugs or devices parallel to or < 1 month before study entry, or previous participation in this study;
- Is an employee of the investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of the employees or the investigator.
About this study
Official title: A Multicenter, Open-label, Randomized, Parallel Group Study to Compare the Efficacy and Safety of Sufentanil Transdermal System (TDS) With Sustained-Release Morphine Sulfate in Patients With Chronic Pain Due to Cancer
The study hypothesis is that the safety and efficacy of sufentanil following transdermal application is comparable to sustained release morphine sulphate tablets in patients with chronic pain due to cancer.
Read the detailed description
The primary objective of this study is to compare the consumption, in milligrams, of rescue analgesia (normal release morphine sulfate tablets) after the administration of sufentanil TDS or sustained release morphine sulfate.
The secondary efficacy objectives of this study are to evaluate:
- Pharmacokinetic data
- Adverse events
- Conditions
- Chronic Pain
- Being tested
- Sufentanil, Sustained Release Morphine Sulfate
- Keywords
- Pain, Cancer, Morphine
- Medical subject headings
- Chronic Pain, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
Transdermal Delivery System; Apply up to six 3 cm2 sufentanil TDS patches every 3 days for 12 days of observation. The 12 days of observation begin after a 7 day conversion to sustained release morphine sulfate. If the subject continues on the pharmacokinetic portion of the study, an additional 6 days of intervention will be evaluated (at the same dose as the primary efficacy study).
Sustained Release Morphine SulfateDrug
Sustained Release Morphine Sulfate tablets every 12 hours; up to 400 mg every day for 19 days (7 days of conversion to sustained release morphine sulfate and 12 days of observation)
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil Transdermal Delivery System | Experimental | Experimental drug Receives: Drug: Sufentanil |
| Control | Active comparator | Sustained release morphine sulfate Receives: Drug: Sustained Release Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The consumption (in mg) of rescue analgesia (normal release morphine sulfate tablets) per day after the administration of either sufentanil TDS or SR morphine sulfate.
Measured: 6 days
Secondary outcomes (2)
Adverse events
Measured: 18 days
Pharmacokinetic data
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: funding for project discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Labtec GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943566
- Sponsor's protocol ID
- STDS0901
- Status last verified
- Jun 2011
- First submitted
- 21 Jul 2009
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Parallel Group Study to Compare the Efficacy and Safety of Sufentanil Transdermal System (TDS) With Sustained-Release Morphine Sulfate in Patients With Chronic Pain Due to Cancer
- ClinicalTrials.gov ID
- NCT00943566
- Acronym / sponsor ID
- STDS0901
- Conditions
- Chronic Pain
- Keywords
- Pain, Cancer, Morphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding for project discontinued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Labtec GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 22 Jul 2009 (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 study hypothesis is that the safety and efficacy of sufentanil following transdermal application is comparable to sustained release morphine sulphate tablets in patients with chronic pain due to cancer.
Detailed description
The primary objective of this study is to compare the consumption, in milligrams, of rescue analgesia (normal release morphine sulfate tablets) after the administration of sufentanil TDS or sustained release morphine sulfate.
The secondary efficacy objectives of this study are to evaluate:
- Pharmacokinetic data
- Adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil Transdermal Delivery System | Experimental | Drug: SufentanilExperimental drug |
| Control | Active comparator | Drug: Sustained Release Morphine SulfateSustained release morphine sulfate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 to 75 with a diagnosis of cancer;
- If female, is non-pregnant (negative pregnancy test at Visit 1) and non-lactating;
- If female, is not of childbearing potential
- Documented history of moderate to severe chronic cancer pain requiring around-the-clock therapy and are likely to benefit from WHO step III opioid analgesics for the duration of the study;
- Has been informed of the nature of the study and has provided written informed consent;
Key exclusion criteria (17 listed)
- Patient is a pregnant or lactating female (serum pregnancy test conducted at the Screening Visit);
- Any ongoing serious adverse events (SAEs) at screening and at baseline;
- Has scheduled elective surgery or other invasive procedures during the period of study participation;
- Patients with a known intolerance to opioid analgesics or any excipient of the Investigational Product;
- Patients with respiratory depression with hypoxia and/or hypercapnia, sever chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus, (obstructive) sleep apnea syndrome;
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 |
|---|---|---|
| SufentanilTransdermal Delivery System; Apply up to six 3 cm2 sufentanil TDS patches every 3 days for 12 days of observation. The 12 days of observation begin after a 7 day conversion to sustained release morphine sulfate. If the subject continues on the pharmacokinetic portion of the study, an additional 6 days of intervention will be evaluated (at the same dose as the primary efficacy study). | Drug | Sufentanil Transdermal Delivery System |
| Sustained Release Morphine SulfateSustained Release Morphine Sulfate tablets every 12 hours; up to 400 mg every day for 19 days (7 days of conversion to sustained release morphine sulfate and 12 days of observation) | Drug | Control |
Primary outcome
The consumption (in mg) of rescue analgesia (normal release morphine sulfate tablets) per day after the administration of either sufentanil TDS or SR morphine sulfate.
Time frame: 6 days
2 secondary outcomes
Adverse events
Time frame: 18 days
Pharmacokinetic data
Time frame: 6 days
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 15 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sufentanil and Sustained Release Morphine Sulfate in people with Chronic Pain, run by Labtec GmbH.
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 17 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 15 Sep 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The consumption (in mg) of rescue analgesia (normal release morphine sulfate tablets) per day after the administration of either sufentanil TDS or SR morphine sulfate. (time frame: 6 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 15 Sep 2015.