Title
2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.
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.
Phase
Phase 2Lead Sponsor
SantoSolve ASStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Amputation Stumps PainIntervention/Treatment
strontium-89 ...Study Participants
22The 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.
Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
Inclusion Criteria: 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 Exclusion Criteria: 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
