Chronic PainPhase 4NCT00196053
The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery
A Phase 4 study testing Archimedes Constant Flow Implantable Pump in people with Chronic Pain, run by Codman & Shurtleff at 8 sites in 3 countries.
Trial summary
The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Archimedes Constant Flow Implantable Pump
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Mar 2005to Aug 2007
- Phase
- Phase 4
- 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
Who may be able to join
- The Subject has been suffering from chronic (benign and/or malignant) intractable pain for at least 2 or more months duration (pending national laws) with a pre-implant value equal or more than 7 on the Visual Analog Pain Scale.
- The subject does not tolerate oral pain medication at the required therapeutic dose to treat his/her pain.
- The Subject has a minimum reasonable life expectancy of at least 6 months.
- The Subject has given written Informed Consent prior to enrollment into this study.
- The body size of the Subject is sufficient to accept the pump bulk and weight, per the Principal Investigator's discretion.
- The Subject is willing to participate in this registry for 1 year post implant and is willing to comply with the investigational plan requirements.
- It is the Principal Investigator's judgment, based on the knowledge of the Subject, and Subject's condition, as well as the features of the implantable system that the Subject is an appropriate candidate for pain management utilizing an implantable pump for continuously delivering preservative-free morphine sulfate via an intrathecal route.
Who cannot join
- The Subject has a skin condition (i.e., scleroderma, psoriasis, rash, or open wound) at the site chosen for implantation that would compromise the integrity or access to the injection port.
- The Subject has previously enrolled in or participated in an investigational drug or device trial within the preceding 4 weeks.
- The Subject has any known contraindication to preservative-free morphine sulfate.
- The Subject has a suspected or documented allergy to preservative-free morphine sulfate or related drugs.
- The Subject has a suspected or documented allergy to the materials of the infusion pump or catheter(s) (for example, silicone).
- The Subject has a history of drug and/or alcohol abuse per Principal Investigator discretion.
- The Subject is a female who is pregnant or lactating.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites
Study site
Bamberg, 81677
Study site
Freiburg im Breisgau, 79106
Study site
Konstanz, 78461
Study site
Meppen, 49704
Study site
Tutzing, 82327
United Kingdom2 sites
Study site
Middlesbrough, TS4 3BW
Study site
Plymoth, PL6 8DH
About this study
Official title: Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery
The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management
Read the detailed description
Pain management has been a long-standing challenge to the medical community, specifically for the treatment of chronic pain. Chronic Pain is defined by the American Chronic Pain Association as "pain that continues a month or more beyond the usual recovery period for an illness or injury or pain that goes on over months or years as a result of a chronic condition." Chronic pain affects the patient's quality of life, work performance and attendance, mental health, social interactions and overall activities of daily living.
Implantable pumps were used for cancer and non-cancer patients, who had pain, which was resistant to conventional therapy. Intrathecal morphine administration is now accepted as a safe and effective method of controlling or reducing pain and its impact on the sufferer.
The Codman ARCHIMEDES Implantable Constant-Flow Infusion Pump is CE marked, and has been commercially available in Europe for intrathecal delivery of morphine and baclofen since August 1997. ARCHIMEDES is intended for the treatment of chronic intractable (cancer or non-cancer) pain, which requires chronic intrathecal infusion of preservative-free morphine sulfate.
This is a European, multicenter, prospective, single arm, observational registry conducted on a total of 150 Subjects at up to 10 centers in Europe.
Subjects will be followed at 3, 6, 9, and 12 months post Archimedes implant to assess their pain management and quality of life.
- Conditions
- Chronic Pain
- Being tested
- Archimedes Constant Flow Implantable Pump
- Keywords
- Intrathecal pain management, constant flow pump
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Archimedes Constant Flow Implantable PumpDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain management measured by the visual analog pain scale
Measured: Quarterly for 1 year post-implant
Pain management measured by quality of life score (SF-36)
Measured: Quarterly for 1 year post-implant
Secondary outcomes (1)
Device-related adverse events over the duration of the study
Measured: End of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2007
- Study completionAug 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Ward, DVM, Study director, Unaffilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196053
- Sponsor's protocol ID
- DDS-EU04-001
- Other IDs
- EU Pain Registry
- Status last verified
- Apr 2012
- First submitted
- 13 Sep 2005
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery
- ClinicalTrials.gov ID
- NCT00196053
- Acronym / sponsor ID
- DDS-EU04-001
- Conditions
- Chronic Pain
- Keywords
- Intrathecal pain management, constant flow pump
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Sep 2005 (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 observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management
Detailed description
Pain management has been a long-standing challenge to the medical community, specifically for the treatment of chronic pain. Chronic Pain is defined by the American Chronic Pain Association as "pain that continues a month or more beyond the usual recovery period for an illness or injury or pain that goes on over months or years as a result of a chronic condition." Chronic pain affects the patient's quality of life, work performance and attendance, mental health, social interactions and overall activities of daily living.
Implantable pumps were used for cancer and non-cancer patients, who had pain, which was resistant to conventional therapy. Intrathecal morphine administration is now accepted as a safe and effective method of controlling or reducing pain and its impact on the sufferer.
The Codman ARCHIMEDES Implantable Constant-Flow Infusion Pump is CE marked, and has been commercially available in Europe for intrathecal delivery of morphine and baclofen since August 1997. ARCHIMEDES is intended for the treatment of chronic intractable (cancer or non-cancer) pain, which requires chronic intrathecal infusion of preservative-free morphine sulfate.
This is a European, multicenter, prospective, single arm, observational registry conducted on a total of 150 Subjects at up to 10 centers in Europe.
Subjects will be followed at 3, 6, 9, and 12 months post Archimedes implant to assess their pain management and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The Subject has been suffering from chronic (benign and/or malignant) intractable pain for at least 2 or more months duration (pending national laws) with a pre-implant value equal or more than 7 on the Visual Analog Pain Scale.
- The subject does not tolerate oral pain medication at the required therapeutic dose to treat his/her pain.
- The Subject has a minimum reasonable life expectancy of at least 6 months.
- The Subject has given written Informed Consent prior to enrollment into this study.
- The body size of the Subject is sufficient to accept the pump bulk and weight, per the Principal Investigator's discretion.
Key exclusion criteria (7 listed)
- The Subject has a skin condition (i.e., scleroderma, psoriasis, rash, or open wound) at the site chosen for implantation that would compromise the integrity or access to the injection port.
- The Subject has previously enrolled in or participated in an investigational drug or device trial within the preceding 4 weeks.
- The Subject has any known contraindication to preservative-free morphine sulfate.
- The Subject has a suspected or documented allergy to preservative-free morphine sulfate or related drugs.
- The Subject has a suspected or documented allergy to the materials of the infusion pump or catheter(s) (for example, silicone).
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 |
|---|---|---|
| Archimedes Constant Flow Implantable Pump | Device | – |
Primary outcome
Pain management measured by the visual analog pain scale
Time frame: Quarterly for 1 year post-implant
Pain management measured by quality of life score (SF-36)
Time frame: Quarterly for 1 year post-implant
1 secondary outcome
Device-related adverse events over the duration of the study
Time frame: End of trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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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.
Michael Ward, DVM study director
Unaffilliated
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Archimedes Constant Flow Implantable Pump in people with Chronic Pain, run by Codman & Shurtleff at 8 sites in 3 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, United Kingdom, France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain management measured by the visual analog pain scale (time frame: Quarterly for 1 year post-implant). The study lists 2 primary outcomes in all. 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 2 May 2012.