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
- Registration Number
- NCT00804375
- Lead Sponsor
- Smerud Medical Research International AS
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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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.
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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.
- 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
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Outpatients, aged 18 years and above
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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.
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Written informed consent
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Patients with forefoot amputations alone are excluded from participation.
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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).
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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.
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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).
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Patients with open wounds, burns or other non-intact skin at site(s) of study drug administration (unhealed stumps).
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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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo placebo 2PX 2PX Pain medication
- Primary Outcome Measures
Name Time Method 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). 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 Outcome Measures
Name Time Method 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). 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
Trial Locations
- Locations (19)
Site in Middlesborough
🇬🇧Middlesborough, United Kingdom
Site in Birmingham
🇬🇧Birmingham, United Kingdom
Site in Crystal Palace
🇬🇧London, United Kingdom
Site in Belfast
🇬🇧Belfast, United Kingdom
Site in St. Petersburg
🇷🇺St. Petersburg, Russian Federation
Site in Manchester
🇬🇧Manchester, United Kingdom
Site in St.Petersburg
🇷🇺St.Petersburg, Russian Federation
Site in Edinburgh
🇬🇧Edinburgh, United Kingdom
Site in Hvidovre
🇩🇰Hvidovre, Denmark
Site in Ålesund
🇳🇴Ålesund, Norway
Site in Glasgow
🇬🇧Glasgow, United Kingdom
Site in Hammersmith
🇬🇧Hammersmith, United Kingdom
Site in Newcastle
🇬🇧Newcastle, United Kingdom
Site in Wiesbaden
🇩🇪Wiesbaden, Germany
Site in Herlev
🇩🇰Herlev, Denmark
Site in Århus
🇩🇰Århus, Denmark
Site in Hamar
🇳🇴Hamar, Norway
Site in Oslo
🇳🇴Oslo, Norway
Site in Stavern
🇳🇴Stavern, Norway