Status:
UNKNOWN
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
Lead Sponsor:
Smerud Medical Research International AS
Collaborating Sponsors:
SantoSolve AS
Conditions:
Stump Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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:
- Stump pain commencing post amputation and continues at Visit 1 despite continued use of analgesic medication
- Stump pain present on a daily basis
- Stump pain intensity as Average stump Pain Intensity (AsPI) ≥40 on 100 mm VAS at Screening
- Stump pain intensity at the randomisation visit: Mean (over the 7 day run-in period) AsPI rating ≥40 on a 100 mm VAS.
- 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.)
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00804375
Start Date
December 1 2008
End Date
June 1 2010
Last Update
March 24 2010
Active Locations (19)
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1
Site in Århus
Aarhus, Denmark
2
Site in Herlev
Herlev, Denmark
3
Site in Hvidovre
Hvidovre, Denmark
4
Site in Wiesbaden
Wiesbaden, Germany