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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SantoSolve AS

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