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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00592098
Other study ID # SMR-1589 / 2PX-SP-01
Secondary ID EUDRACT no: 2006
Status Completed
Phase Phase 2
First received December 29, 2007
Last updated January 10, 2008
Start date August 2007
Est. completion date December 2007

Study information

Verified date December 2007
Source SantoSolve AS
Contact n/a
Is FDA regulated No
Health authority Norway: Medicines Control Agency
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Strontium chloride hexahydrate
Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
Placebo
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Locations

Country Name City State
Norway Smerud Investigator site 1 Oslo

Sponsors (1)

Lead Sponsor Collaborator
SantoSolve AS

Country where clinical trial is conducted

Norway, 

Outcome

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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