MedTrace Logo

Study of the Efficacy, Safety and Tolerability of Topical 2PX (Strontium Chloride Hexahydrate) in Patients With Chronic, Moderate-to-severe Lower Limb Post-amputation Stump Pain

NCT00804375 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-03-24

No results posted yet for this study

Summary

Primary: To compare the analgesic effect over 12 weeks of topical 2PX in stump pain.

Secondary: To prospectively measure other efficacy and safety variables of topical 2PX in stump pain. Exploratory analyses will be performed to measure efficacy and safety variables of topical 2PX in phantom pain

Conditions

  • Stump Pain

Interventions

DRUG

2PX

cutaneous solution to be applied twice daily for 84 days

DRUG

Placebo

cutaneous solution to be applied twice daily for 84 days

Sponsors & Collaborators

  • SantoSolve AS

    collaborator INDUSTRY

  • Smerud Medical Research International AS

    lead OTHER

Principal Investigators

  • Lone Nikolajsen, MD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Denmark
  • Germany
  • Norway
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804375 on ClinicalTrials.gov