Stump PainPhase 2NCT00804375
Study of the Efficacy, Safety and Tolerability of Topical 2PX (Strontium Chloride Hexahydrate) in Patients With Chronic, Moderate-to-severe Lower Limb Post-amputation Stump Pain
A Phase 2 study testing 2PX in people with Stump Pain, run by Smerud Medical Research International AS at 19 sites in 5 countries.
Trial summary
Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain. Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in stump pain. Exploratory analyses will be performed to measure efficacy and safety variables of topical 2PX in phantom pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stump Pain
- What is being tested?
- 2PX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Dec 2008to Jun 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lower limb amputation at least 6 months prior to Visit 1. Amputation must be transtibial, transfemoral or through the knee. For patients with transfemoral amputation, the point of amputation must be ≥10 cm from the inguinal region.
- Presenting with moderate-to-severe stump pain. For the purpose of this study, the following criteria must all apply:
- Stump pain commencing post amputation and continues at Visit 1 despite continued use of analgesic medication
- Stump pain present on a daily basis
- Stump pain intensity as Average stump Pain Intensity (AsPI) ≥40 on 100 mm VAS at Screening
- Stump pain intensity at the randomisation visit: Mean (over the 7 day run-in period) AsPI rating ≥40 on a 100 mm VAS.
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- Pain at the site of the extremity amputation. The pain is located mainly in the stump itself. (Patients with concurrent phantom pain may be enrolled in the study.)
- Stump pain persists despite proper healing of the stump
- Outpatients, aged 18 years and above
- Underlying therapy (e.g., rehabilitation procedures, analgesia, physio-therapy, spinal cord stimulation (except for topical or subcutaneous local analgesics)) may be continued throughout the duration of the study, if the regimen has been stable during the 4 weeks immediately prior to Visit 1. If underlying therapy is continued during the study the regimen must be maintained for the duration of the study.
- Written informed consent
Who cannot join
- Patients with forefoot amputations alone are excluded from participation.
- Patients who have received treatment with any topical or subcutaneously administered analgesic agent for stump or phantom pain in the 4 weeks prior to study entry (i.e. Visit 1).
- Underlying therapy (e.g., rehabilitation procedures, analgesia, physio-therapy, spinal cord stimulation) is not permitted if the regimen has not been stable in the 4 weeks immediately prior to Visit 1.
- After the 7 day run-in phase: patients taking any new or changing the dose of any underlying analgesic medication (except for rescue medication as defined in this protocol).
- Patients with open wounds, burns or other non-intact skin at site(s) of study drug administration (unhealed stumps).
- Patients with significant discomfort from their prosthesis limiting use of the prosthesis. Use of a prosthesis is not a requirement for participation in the study.
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- Pregnancy
- Female patients of childbearing potential unwilling to use adequate contraception measures throughout the duration of the study. For the purpose of this study, adequate contraception is defined as:
- oral, injected or implanted hormonal methods of contraception; OR
- placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
- barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository Note: Male sterilization or abstinence are not acceptable methods of birth control and would preclude enrolment in the study.
- Note: For post-menopausal women: less than 12 months since the last spontaneous menstrual bleeding will exclude the patient unless they are willing to utilise acceptable methods of contraception for the duration of the study.
- Breast-feeding/lactating mothers
- Any active malignant disease (except basal cell carcinoma; BCC)
- Patients who have previously received 2PX.
- Patients requiring concomitant administration of strontium ranelate (Protelos®)
- Patients who have received an investigational drug or used an investigational device within the 30 days prior to study entry.
- Patients unable to comply with the study assessments
- Patients with documented or suspected current alcohol or drug abuse
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United Kingdom9 sites
- Completed
Site in Belfast
Belfast
- Completed
Site in Birmingham
Birmingham
- Completed
Site in Edinburgh
Edinburgh
- Completed
Site in Glasgow
Glasgow
- Completed
Site in Hammersmith
Hammersmith
- Completed
Site in Crystal Palace
London
- Completed
Site in Manchester
Manchester
- Completed
Site in Middlesborough
Middlesbrough
- Completed
Site in Newcastle
Newcastle
Norway4 sites
- Completed
Site in Ålesund
Ålesund
- Completed
Site in Hamar
Hamar
- Completed
Site in Oslo
Oslo
- Completed
Site in Stavern
Stavern
Denmark3 sites
- Completed
Site in Århus
Aarhus
- Completed
Site in Herlev
Herlev
- Completed
Site in Hvidovre
Hvidovre
Russia2 sites, 2 recruiting
- Recruiting
Site in St. Petersburg
Saint Petersburg
- Recruiting
Site in St.Petersburg
Saint Petersburg
About this study
Official title: Study of the Efficacy, Safety and Tolerability of Topical 2PX (Strontium Chloride Hexahydrate) in Patients With Chronic, Moderate-to-severe Lower Limb Post-amputation Stump Pain.
Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain.
Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in stump pain. Exploratory analyses will be performed to measure efficacy and safety variables of topical 2PX in phantom pain
- Conditions
- Stump Pain
- Being tested
- 2PX, Placebo
- Keywords
- stump pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2PXDrug
cutaneous solution to be applied twice daily for 84 days
PlaceboDrug
cutaneous solution to be applied twice daily for 84 days
| Study group | Role | What they receive |
|---|---|---|
| 2PX | Experimental | Pain medication Receives: Drug: 2PX |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average (stump) Pain Intensity (AsPI): and recorded in the diary in response to the question: 'What was your average stump pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Measured: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication)
Secondary outcomes (1)
Worst (stump) Pain Intensity (WsPI): recorded in the diary in response to the question: 'What was your worst stump pain level during the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Measured: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stump 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smerud Medical Research International AS
- Sponsor type
- University, hospital or other
- Collaborators
- SantoSolve AS
- Investigators
- Lone Nikolajsen, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804375
- Sponsor's protocol ID
- 2PX-SP-02
- Other IDs
- SMR-1850
- Status last verified
- Mar 2010
- First submitted
- 5 Dec 2008
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy, Safety and Tolerability of Topical 2PX (Strontium Chloride Hexahydrate) in Patients With Chronic, Moderate-to-severe Lower Limb Post-amputation Stump Pain.
- ClinicalTrials.gov ID
- NCT00804375
- Acronym / sponsor ID
- 2PX-SP-02
- Conditions
- Stump Pain
- Keywords
- stump pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Smerud Medical Research International ASUniversity, hospital or other
- Collaborators
- SantoSolve AS
- Study start
- Dec 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 8 Dec 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.
Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain.
Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in stump pain. Exploratory analyses will be performed to measure efficacy and safety variables of topical 2PX in phantom pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2PX | Experimental | Drug: 2PXPain medication |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Lower limb amputation at least 6 months prior to Visit 1. Amputation must be transtibial, transfemoral or through the knee. For patients with transfemoral amputation, the point of amputation must be ≥10 cm from the inguinal region.
- Presenting with moderate-to-severe stump pain. For the purpose of this study, the following criteria must all apply:
- Outpatients, aged 18 years and above
- Underlying therapy (e.g., rehabilitation procedures, analgesia, physio-therapy, spinal cord stimulation (except for topical or subcutaneous local analgesics)) may be continued throughout the duration of the study, if the regimen has been stable during the 4 weeks immediately prior to Visit 1. If underlying therapy is continued during the study the regimen must be maintained for the duration of the study.
- Written informed consent
Key exclusion criteria (19 listed)
- Patients with forefoot amputations alone are excluded from participation.
- Patients who have received treatment with any topical or subcutaneously administered analgesic agent for stump or phantom pain in the 4 weeks prior to study entry (i.e. Visit 1).
- Underlying therapy (e.g., rehabilitation procedures, analgesia, physio-therapy, spinal cord stimulation) is not permitted if the regimen has not been stable in the 4 weeks immediately prior to Visit 1.
- After the 7 day run-in phase: patients taking any new or changing the dose of any underlying analgesic medication (except for rescue medication as defined in this protocol).
- Patients with open wounds, burns or other non-intact skin at site(s) of study drug administration (unhealed stumps).
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 |
|---|---|---|
| 2PXcutaneous solution to be applied twice daily for 84 days | Drug | 2PX |
| Placebocutaneous solution to be applied twice daily for 84 days | Drug | placebo |
Primary outcome
Average (stump) Pain Intensity (AsPI): and recorded in the diary in response to the question: 'What was your average stump pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Time frame: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication)
1 secondary outcome
Worst (stump) Pain Intensity (WsPI): recorded in the diary in response to the question: 'What was your worst stump pain level during the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Time frame: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
Related trials for Stump Pain
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Not yet recruitingObservational study
Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
Residual Limb Pain, Stump Pain
Not yet recruitingObservational study
Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain
Amputation Stump, Amputation Neuroma
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.
Lone Nikolajsen, MD principal investigator
Aarhus University Hospital
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2PX in people with Stump Pain, run by Smerud Medical Research International AS at 19 sites in 5 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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom, Norway, Denmark, Russia, Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Macnair, PhD (+44 1357 523481, bob.macnair@smerud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average (stump) Pain Intensity (AsPI): and recorded in the diary in response to the question: 'What was your average stump pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable). (time frame: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication)). 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 24 Mar 2010.