Amputation StumpsPhase 2NCT00592098
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
A Phase 2 study testing Strontium chloride hexahydrate in people with Amputation Stumps and Pain, run by SantoSolve AS at 1 site in Norway.
Trial summary
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation Stumps, Pain
- What is being tested?
- Strontium chloride hexahydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2007to Dec 2007
- 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 inclusion
- Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS
- Outpatients, aged 18 years and above
- Written informed consent
Who cannot join
- Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation)
- Subjects taking any analgesic medication (except for rescue medication as defined in this protocol)
- Subjects with expressed dissatisfaction with their prosthesis comfort
- Pregnant or breast-feeding women
- Any malignant disease
- Subjects who have received an investigational drug or used an investigational device in the 30 days prior to study entry.
- Subjects unable to comply with the study assessments
- Subjects with documented or suspected alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Persistent, Moderate-to-Severe Lower Limb Post-Amputation Stump Pain.
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
- Conditions
- Amputation Stumps, Pain
- Being tested
- Strontium chloride hexahydrate, Placebo
- Keywords
- Lower limb amputation at least 6 months prior to inclusion, Presenting with moderate-to-severe pain intensity, Outpatients, aged 18 years and above
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium chloride hexahydrateDrug
Also called 2PX
Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
PlaceboDrug
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2PX Receives: Drug: Strontium chloride hexahydrate |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Measured: 24 hours
Secondary outcomes (9)
• Worst Pain Intensity (WPI)
Measured: 24 hours
• Pain relief
Measured: Weekly
• Sleep disturbance
Measured: 24 hours
• Use of rescue medication
Measured: Daily
• Patient Global Impression of Change (PGIC)
Measured: Weekly
• Prosthesis bothersomeness
Measured: Weekly
• Quality of life assessment
Measured: Q 14 days
Local skin irritability
Measured: Q 14 days
Adverse events
Measured: Q 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation StumpsStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SantoSolve AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Knut T Smerud, MSc, Study director, Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592098
- Sponsor's protocol ID
- SMR-1589 / 2PX-SP-01
- Other IDs
- EUDRACT no: 2006-005447-29
- Status last verified
- Dec 2007
- First submitted
- 29 Dec 2007
- Last updated
- 11 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Persistent, Moderate-to-Severe Lower Limb Post-Amputation Stump Pain.
- ClinicalTrials.gov ID
- NCT00592098
- Acronym / sponsor ID
- SMR-1589 / 2PX-SP-01
- Conditions
- Amputation Stumps, Pain
- Keywords
- Lower limb amputation at least 6 months prior to inclusion, Presenting with moderate-to-severe pain intensity, Outpatients, aged 18 years and above
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- SantoSolve ASIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Jan 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 objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Strontium chloride hexahydrate2PX |
| 2 | 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 (4 listed)
- Lower limb amputation at least 6 months prior to inclusion
- Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS
- Outpatients, aged 18 years and above
- Written informed consent
Key exclusion criteria (8 listed)
- Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation)
- Subjects taking any analgesic medication (except for rescue medication as defined in this protocol)
- Subjects with expressed dissatisfaction with their prosthesis comfort
- Pregnant or breast-feeding women
- Any malignant disease
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 |
|---|---|---|
| Strontium chloride hexahydrateAlso: 2PXCutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days. | Drug | 1 |
| PlaceboCutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days. | Drug | 2 |
Primary outcome
Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Time frame: 24 hours
9 secondary outcomes
• Worst Pain Intensity (WPI)
Time frame: 24 hours
• Pain relief
Time frame: Weekly
• Sleep disturbance
Time frame: 24 hours
• Use of rescue medication
Time frame: Daily
• Patient Global Impression of Change (PGIC)
Time frame: Weekly
• Prosthesis bothersomeness
Time frame: Weekly
• Quality of life assessment
Time frame: Q 14 days
Local skin irritability
Time frame: Q 14 days
Adverse events
Time frame: Q 14 days
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 11 Jan 2008.
Related trials for Amputation Stumps
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
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Amputation Stump, Burn Injury
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Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
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Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
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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
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.
Knut T Smerud, MSc study director
Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Strontium chloride hexahydrate in people with Amputation Stumps and Pain, run by SantoSolve AS at 1 site in Norway.
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 8 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 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
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?
Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable). (time frame: 24 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 11 Jan 2008.