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

Sponsor
SantoSolve AS (Industry)
Overall Status
Completed
CT.gov ID
NCT00592098
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
4
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Strontium chloride hexahydrate
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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.

    Outcome Measures

    Primary Outcome Measures

    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). [24 hours]

    Secondary Outcome Measures

    1. • Worst Pain Intensity (WPI) [24 hours]

    2. • Pain relief [Weekly]

    3. • Sleep disturbance [24 hours]

    4. • Use of rescue medication [Daily]

    5. • Patient Global Impression of Change (PGIC) [Weekly]

    6. • Prosthesis bothersomeness [Weekly]

    7. • Quality of life assessment [Q 14 days]

    8. Local skin irritability [Q 14 days]

    9. Adverse events [Q 14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Smerud Investigator site 1 Oslo Norway

    Sponsors and Collaborators

    • SantoSolve AS

    Investigators

    • Study Director: Knut T Smerud, MSc, Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00592098
    Other Study ID Numbers:
    • SMR-1589 / 2PX-SP-01
    • EUDRACT no: 2006-005447-29
    First Posted:
    Jan 11, 2008
    Last Update Posted:
    Jan 11, 2008
    Last Verified:
    Dec 1, 2007
    Keywords provided by , ,
    Lower limb amputation at least 6 months prior to inclusion
    Presenting with moderate-to-severe pain intensity
    Outpatients, aged 18 years and above

    Study Results

    No Results Posted as of Jan 11, 2008