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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Amputation Stumps Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

2PX

Group Type EXPERIMENTAL

Strontium chloride hexahydrate

Intervention Type DRUG

Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Interventions

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Strontium chloride hexahydrate

Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Intervention Type DRUG

Placebo

Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Intervention Type DRUG

Other Intervention Names

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2PX

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No