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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592098
• Other study ID #: SMR-1589 / 2PX-SP-01
• Secondary ID: EUDRACT no: 2006
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2007
• Last updated: January 10, 2008
• Start date: August 2007
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: SantoSolve AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Medicines Control Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation Stumps
• Pain

Intervention

Drug:
• Strontium chloride hexahydrate
Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
• Placebo
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Locations

Country	Name	City	State
Norway	Smerud Investigator site 1	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
SantoSolve AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• Worst Pain Intensity (WPI)		24 hours	No
Secondary	• Pain relief		Weekly	No
Secondary	• Sleep disturbance		24 hours	No
Secondary	• Use of rescue medication		Daily	No
Secondary	• Patient Global Impression of Change (PGIC)		Weekly	No
Secondary	• Prosthesis bothersomeness		Weekly	No
Secondary	• Quality of life assessment		Q 14 days	No
Secondary	Local skin irritability		Q 14 days	Yes
Secondary	Adverse events		Q 14 days	Yes