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

Smerud Medical Research

Status and phase: Unknown; Phase 2

Conditions: Stump Pain

Treatments: Drug: Placebo; Drug: 2PX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00804375

SMR-1850

2PX-SP-02

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

2PX

Experimental group

Description:

Pain medication

Treatment:

Drug: 2PX

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo