2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.

Study Overview
=================
Brief 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.

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.

Conditions
-----------------
Amputation Stumps, Pain

Intervention / Treatment
-----------------
* Drug: Strontium chloride hexahydrate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>2PX | Drug: Strontium chloride hexahydrate<br>* Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.<br>* Other names: 2PX;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Worst Pain Intensity (WPI) |  | 24 hours | 
| • Pain relief |  | Weekly | 
| • Sleep disturbance |  | 24 hours | 
| • Use of rescue medication |  | Daily | 
| • Patient Global Impression of Change (PGIC) |  | Weekly | 
| • Prosthesis bothersomeness |  | Weekly | 
| • Quality of life assessment |  | Q 14 days | 
| Local skin irritability |  | Q 14 days | 
| Adverse events |  | Q 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower limb amputation at least 6 months prior to inclusion, Presenting with moderate-to-severe pain intensity, Outpatients, aged 18 years and above