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

Stump Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00804375
• Other study ID #: 2PX-SP-02
• Secondary ID: SMR-1850
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2008
• Last updated: March 22, 2010
• Start date: December 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2010
• Source: Smerud Medical Research International AS
• Contact: Robert Macnair, PhD
• Phone: +44 1357 523481
• Email: bob.macnair[@]smerud.com
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyDenmark: Danish Medicines AgencyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stump Pain

Intervention

Drug:
• 2PX
cutaneous solution to be applied twice daily for 84 days
• Placebo
cutaneous solution to be applied twice daily for 84 days

Locations

Country	Name	City	State
Denmark	Site in Århus	Århus
Denmark	Site in Herlev	Herlev
Denmark	Site in Hvidovre	Hvidovre
Germany	Site in Wiesbaden	Wiesbaden
Norway	Site in Ålesund	Ålesund
Norway	Site in Hamar	Hamar
Norway	Site in Oslo	Oslo
Norway	Site in Stavern	Stavern
Russian Federation	Site in St. Petersburg	St. Petersburg
Russian Federation	Site in St.Petersburg	St.Petersburg
United Kingdom	Site in Belfast	Belfast
United Kingdom	Site in Birmingham	Birmingham
United Kingdom	Site in Edinburgh	Edinburgh
United Kingdom	Site in Glasgow	Glasgow
United Kingdom	Site in Hammersmith	Hammersmith
United Kingdom	Site in Crystal Palace	London
United Kingdom	Site in Manchester	Manchester
United Kingdom	Site in Middlesborough	Middlesborough
United Kingdom	Site in Newcastle	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
Smerud Medical Research International AS	SantoSolve AS

Countries where clinical trial is conducted

Denmark,  Germany,  Norway,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		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)	No
Secondary	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).		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	No