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
Information source: Smerud Medical Research International AS
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stump Pain
Intervention: 2PX (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Smerud Medical Research International AS Official(s) and/or principal investigator(s): Lone Nikolajsen, MD, Principal Investigator, Affiliation: Aarhus University Hospital
Overall contact: Robert Macnair, PhD, Phone: +44 1357 523481, Email: bob.macnair@smerud.com
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
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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).
Secondary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Robert Macnair, PhD, Phone: +44 1357 523481, Email: bob.macnair@smerud.com
Site in Herlev, Herlev, Denmark; Completed
Site in Hvidovre, Hvidovre, Denmark; Completed
Site in Århus, Århus, Denmark; Completed
Site in Wiesbaden, Wiesbaden, Germany; Recruiting
Site in Hamar, Hamar, Norway; Completed
Site in Oslo, Oslo, Norway; Completed
Site in Stavern, Stavern, Norway; Completed
Site in Ålesund, Ålesund, Norway; Completed
Site in St. Petersburg, St. Petersburg, Russian Federation; Recruiting
Site in St.Petersburg, St.Petersburg, Russian Federation; Recruiting
Site in Belfast, Belfast, United Kingdom; Completed
Site in Birmingham, Birmingham, United Kingdom; Completed
Site in Edinburgh, Edinburgh, United Kingdom; Completed
Site in Glasgow, Glasgow, United Kingdom; Completed
Site in Hammersmith, Hammersmith, United Kingdom; Completed
Site in Crystal Palace, London, United Kingdom; Completed
Site in Manchester, Manchester, United Kingdom; Completed
Site in Middlesborough, Middlesborough, United Kingdom; Completed
Site in Newcastle, Newcastle, United Kingdom; Completed
Additional Information
Starting date: December 2008
Last updated: March 22, 2010
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