Pain Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Cross-Over Study to Evaluate the Efficacy of 2PX (Topical Strontium Chloride Hexahydrate) in Patients With Persistent, Moderate-to-Severe Lower Limb Post-Amputation Stump Pain.
Verified date | December 2007 |
Source | SantoSolve AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Medicines Control Agency |
Study type | Interventional |
The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Lower limb amputation at least 6 months prior to inclusion - Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS - Outpatients, aged 18 years and above - Written informed consent Exclusion Criteria: - Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation) - Subjects taking any analgesic medication (except for rescue medication as defined in this protocol) - Subjects with expressed dissatisfaction with their prosthesis comfort - Pregnant or breast-feeding women - Any malignant disease - Subjects who have received an investigational drug or used an investigational device in the 30 days prior to study entry. - Subjects unable to comply with the study assessments - Subjects with documented or suspected alcohol or drug abuse |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Smerud Investigator site 1 | Oslo |
Lead Sponsor | Collaborator |
---|---|
SantoSolve AS |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable). | 24 hours | No | |
Secondary | • Worst Pain Intensity (WPI) | 24 hours | No | |
Secondary | • Pain relief | Weekly | No | |
Secondary | • Sleep disturbance | 24 hours | No | |
Secondary | • Use of rescue medication | Daily | No | |
Secondary | • Patient Global Impression of Change (PGIC) | Weekly | No | |
Secondary | • Prosthesis bothersomeness | Weekly | No | |
Secondary | • Quality of life assessment | Q 14 days | No | |
Secondary | Local skin irritability | Q 14 days | Yes | |
Secondary | Adverse events | Q 14 days | Yes |
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