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Completed

NCT Number: NCT00592098

2PX (Topical Strontium Chloride Hexahydrate) in Patients With 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.

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Key information

Conditions

Amputation Stumps Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Smerud Investigator site 1

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strontium chloride hexahydrate

Drug

Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Other names: 2PX

Placebo

Drug

Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Primary outcomes

  1. 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

Secondary outcomes

  1. • Worst Pain Intensity (WPI)

    Time frame: 24 hours

  2. • Pain relief

    Time frame: Weekly

  3. • Sleep disturbance

    Time frame: 24 hours

  4. • Use of rescue medication

    Time frame: Daily

  5. • Patient Global Impression of Change (PGIC)

    Time frame: Weekly

  6. • Prosthesis bothersomeness

    Time frame: Weekly

  7. • Quality of life assessment

    Time frame: Q 14 days

  8. Local skin irritability

    Time frame: Q 14 days

  9. Adverse events

    Time frame: Q 14 days

Sponsors and collaborators

Lead sponsor

SantoSolve AS

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 11, 2008
Registry last updated
Jan 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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