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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Smerud Medical Research International AS.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
SantoSolve AS
Information provided by:
Smerud Medical Research International AS
ClinicalTrials.gov Identifier:
NCT00804375
First received: December 5, 2008
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Stump Pain
Drug: 2PX
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Further study details as provided by Smerud Medical Research International AS:

Primary Outcome Measures:
  • Average (stump) Pain Intensity (AsPI): and recorded in the diary in response to the question: 'What was your average stump pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable). [ Time Frame: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Worst (stump) Pain Intensity (WsPI): recorded in the diary in response to the question: 'What was your worst stump pain level during the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable). [ Time Frame: will be measured each evening (at least 1 hour after taking off the prosthesis, if applicable, and immediately prior to administering the evening dose of study medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2PX
Pain medication
Drug: 2PX
cutaneous solution to be applied twice daily for 84 days
Placebo Comparator: placebo
placebo
Drug: Placebo
cutaneous solution to be applied twice daily for 84 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lower limb amputation at least 6 months prior to Visit 1. Amputation must be transtibial, transfemoral or through the knee. For patients with transfemoral amputation, the point of amputation must be ≥10 cm from the inguinal region.
  • Presenting with moderate-to-severe stump pain. For the purpose of this study, the following criteria must all apply:

    1. Stump pain commencing post amputation and continues at Visit 1 despite continued use of analgesic medication
    2. Stump pain present on a daily basis
    3. Stump pain intensity as Average stump Pain Intensity (AsPI) ≥40 on 100 mm VAS at Screening
    4. Stump pain intensity at the randomisation visit: Mean (over the 7 day run-in period) AsPI rating ≥40 on a 100 mm VAS.
    5. Pain at the site of the extremity amputation. The pain is located mainly in the stump itself. (Patients with concurrent phantom pain may be enrolled in the study.)
    6. Stump pain persists despite proper healing of the stump
  • Outpatients, aged 18 years and above
  • Underlying therapy (e.g., rehabilitation procedures, analgesia, physio-therapy, spinal cord stimulation (except for topical or subcutaneous local analgesics)) may be continued throughout the duration of the study, if the regimen has been stable during the 4 weeks immediately prior to Visit 1. If underlying therapy is continued during the study the regimen must be maintained for the duration of the study.
  • Written informed consent

Exclusion Criteria:

  • Patients with forefoot amputations alone are excluded from participation.
  • Patients who have received treatment with any topical or subcutaneously administered analgesic agent for stump or phantom pain in the 4 weeks prior to study entry (i.e. Visit 1).
  • Underlying therapy (e.g., rehabilitation procedures, analgesia, physio-therapy, spinal cord stimulation) is not permitted if the regimen has not been stable in the 4 weeks immediately prior to Visit 1.
  • After the 7 day run-in phase: patients taking any new or changing the dose of any underlying analgesic medication (except for rescue medication as defined in this protocol).
  • Patients with open wounds, burns or other non-intact skin at site(s) of study drug administration (unhealed stumps).
  • Patients with significant discomfort from their prosthesis limiting use of the prosthesis. Use of a prosthesis is not a requirement for participation in the study.
  • Pregnancy
  • Female patients of childbearing potential unwilling to use adequate contraception measures throughout the duration of the study. For the purpose of this study, adequate contraception is defined as:

    • oral, injected or implanted hormonal methods of contraception; OR
    • placement of an intrauterine device (IUD) or intrauterine system (IUS); OR
    • barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository Note: Male sterilization or abstinence are not acceptable methods of birth control and would preclude enrolment in the study.

Note: For post-menopausal women: less than 12 months since the last spontaneous menstrual bleeding will exclude the patient unless they are willing to utilise acceptable methods of contraception for the duration of the study.

  • Breast-feeding/lactating mothers
  • Any active malignant disease (except basal cell carcinoma; BCC)
  • Patients who have previously received 2PX.
  • Patients requiring concomitant administration of strontium ranelate (Protelos®)
  • Patients who have received an investigational drug or used an investigational device within the 30 days prior to study entry.
  • Patients unable to comply with the study assessments
  • Patients with documented or suspected current alcohol or drug abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804375

Contacts
Contact: Robert Macnair, PhD +44 1357 523481 bob.macnair@smerud.com

Locations
Denmark
Site in Herlev Completed
Herlev, Denmark
Site in Hvidovre Completed
Hvidovre, Denmark
Site in Århus Completed
Århus, Denmark
Germany
Site in Wiesbaden Recruiting
Wiesbaden, Germany
Norway
Site in Hamar Completed
Hamar, Norway
Site in Oslo Completed
Oslo, Norway
Site in Stavern Completed
Stavern, Norway
Site in Ålesund Completed
Ålesund, Norway
Russian Federation
Site in St. Petersburg Recruiting
St. Petersburg, Russian Federation
Site in St.Petersburg Recruiting
St.Petersburg, Russian Federation
United Kingdom
Site in Belfast Completed
Belfast, United Kingdom
Site in Birmingham Completed
Birmingham, United Kingdom
Site in Edinburgh Completed
Edinburgh, United Kingdom
Site in Glasgow Completed
Glasgow, United Kingdom
Site in Hammersmith Completed
Hammersmith, United Kingdom
Site in Crystal Palace Completed
London, United Kingdom
Site in Manchester Completed
Manchester, United Kingdom
Site in Middlesborough Completed
Middlesborough, United Kingdom
Site in Newcastle Completed
Newcastle, United Kingdom
Sponsors and Collaborators
Smerud Medical Research International AS
SantoSolve AS
Investigators
Principal Investigator: Lone Nikolajsen, MD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Thorfinn Ege, SantoSolve AS
ClinicalTrials.gov Identifier: NCT00804375     History of Changes
Other Study ID Numbers: 2PX-SP-02, SMR-1850
Study First Received: December 5, 2008
Last Updated: March 22, 2010
Health Authority: Norway: Norwegian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by Smerud Medical Research International AS:
stump pain

ClinicalTrials.gov processed this record on October 19, 2014