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

January 10, 2008 updated by: SantoSolve AS

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Smerud Investigator site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Placebo
Drug: Placebo
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
EXPERIMENTAL: 1
2PX
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.
Other Names:
  • 2PX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
• Worst Pain Intensity (WPI)
Time Frame: 24 hours
24 hours
• Pain relief
Time Frame: Weekly
Weekly
• Sleep disturbance
Time Frame: 24 hours
24 hours
• Use of rescue medication
Time Frame: Daily
Daily
• Patient Global Impression of Change (PGIC)
Time Frame: Weekly
Weekly
• Prosthesis bothersomeness
Time Frame: Weekly
Weekly
• Quality of life assessment
Time Frame: Q 14 days
Q 14 days
Local skin irritability
Time Frame: Q 14 days
Q 14 days
Adverse events
Time Frame: Q 14 days
Q 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SantoSolve AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

December 29, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (ESTIMATE)

January 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SMR-1589 / 2PX-SP-01
  • EUDRACT no: 2006-005447-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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