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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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02221934 - Electrical Nerve Block for Amputation Pain N/A
Completed NCT03317600 - Postamputation Pain: Peripheral Mechanisms N/A
Terminated NCT00768248 - Naval Medical Center San Diego (NMCSD) - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain N/A
Terminated NCT00771862 - Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study Phase 4
Completed NCT00667264 - Ambulatory Continuous Peripheral Nerve Blocks for Treatment of Post-Amputation Phantom Limb and Stump Pain N/A
Completed NCT00462566 - The Efficacy of Motor Cortex Stimulation for Pain Control N/A