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

SantoSolve

Status and phase

Completed

Phase 2

Conditions

Pain

Amputation Stumps

Treatments

Drug: Strontium chloride hexahydrate

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00592098

SMR-1589 / 2PX-SP-01

EUDRACT no: 2006-005447-29

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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