Post amputation patients (at least 6 months prior to visit 1) with chronic moderate-to-severe lower limb stump pain, defined as average stump pain on a daily basis (=40 on a 100 mm pain VAS scale) despite proper healing of the wound. Patients with concurrent phantom pain may also be enrolled in the study. MedDRA version: 9.1 Level: LLT Classification code 10023931 Term: Late amputation stump complication
Conditions
Interventions
Product Name: 2PX
Product Code: 2PX
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: strontium chloride hexahydrate
Current Sponsor code: 2PX
Other descriptive name: 2PX
Concentration unit
Sponsors
SantoSolve A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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: a) Stump pain commencing post amputation and continues at Visit 1 despite continued use of analgesic medication b) Stump pain present on a daily basis c) Stump pain intensity as API (=40 on 100 mm VAS) at Screening d) Stump pain intensity at the randomisation visit: Mean (over the 7 day run-in period) stump API rating =40 on a 100 mm VAS. e) 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. f) 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 New in amendment 2: - Patients must have at least one identifiable activated trigger point which results in referred stump pain. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients with forefoot amputations alone are excluded from participation. •Subjects 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: subjects taking any new or changing the dose of any underlying analgesic medication (except for rescue medication as defined in this protocol). •Subjects with open wounds, burns or other non-intact skin at site(s) of study drug administration (unhealed stumps). •Subjects with significant discomfort from their prosthesis limiting use of the prosthesis. Use of a prosthesis is not a requirement for participation in the study. •Pregnancy •Female subjects 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: o oral, injected or implanted hormonal methods of contraception; OR o placement of an intrauterine device (IUD) or intrauterine system (IUS); OR o 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 utilize acceptable methods of contraception for the duration of the study. •Breast-feeding/lactating mothers •Any active malignant disease (except basal cell carcinoma; BCC) •Subjects who have previously received 2PX. •Subjects requiring concomitant administration of strontium ranelate (Protelos®) •Subjects who have received an investigational drug or used an investigational device within the 30 days prior to study entry. •Subjects unable to comply with the study assessments •Subjects with documented or suspected current alcohol or drug abuse New in amendment 2: - Patients with bilateral lower limb amputations are excluded from the trial. - Patients requiring more than 10 mls of study medication to be applied per day are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain. ;Secondary Objective: 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. ;Primary end point(s): Primary efficacy variable: Average (stump) Pain Intensity (AsPI): will be measured each evening (at least 1 hour after taking off the prosthesis and immediately prior to administering the evening dose of study medication) 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). | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed