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

Phase 2

Completed

• Conditions: Amputation Stumps; Pain
• Interventions: Drug: Strontium chloride hexahydrate; Drug: Placebo

• Registration Number: NCT00592098
• Lead Sponsor: SantoSolve AS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Status Verified: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-29
• Study First Submitted QC: 2008-01-10
• Last Update Submitted: 2008-01-10
• Study First Posted: 2008-01-11
• Last Update Posted: 2008-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Strontium chloride hexahydrate	2PX
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
• 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

Trial Locations

Locations (1)

Smerud Investigator site 1; 🇳🇴 Oslo, Norway