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2PX (Topical Strontium Chloride Hexahydrate) in Patients With Post-Amputation Stump Pain.

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ClinicalTrials.gov Identifier: NCT00592098
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : January 11, 2008
Sponsor:
Information provided by:
SantoSolve AS

Brief 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.

Condition or disease Intervention/treatment Phase
Amputation Stumps Pain Drug: Strontium chloride hexahydrate Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : August 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
2PX
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.
Other Name: 2PX
Placebo Comparator: 2
Placebo
Drug: Placebo
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.



Primary Outcome Measures :
  1. 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). [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. • Worst Pain Intensity (WPI) [ Time Frame: 24 hours ]
  2. • Pain relief [ Time Frame: Weekly ]
  3. • Sleep disturbance [ Time Frame: 24 hours ]
  4. • Use of rescue medication [ Time Frame: Daily ]
  5. • Patient Global Impression of Change (PGIC) [ Time Frame: Weekly ]
  6. • Prosthesis bothersomeness [ Time Frame: Weekly ]
  7. • Quality of life assessment [ Time Frame: Q 14 days ]
  8. Local skin irritability [ Time Frame: Q 14 days ]
  9. Adverse events [ Time Frame: Q 14 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592098


Locations
Norway
Smerud Investigator site 1
Oslo, Norway
Sponsors and Collaborators
SantoSolve AS
Investigators
Study Director: Knut T Smerud, MSc Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway

Responsible Party: Thorfinn Ege, SantoSolve AS
ClinicalTrials.gov Identifier: NCT00592098     History of Changes
Other Study ID Numbers: SMR-1589 / 2PX-SP-01
EUDRACT no: 2006-005447-29
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: December 2007

Keywords provided by SantoSolve AS:
Lower limb amputation at least 6 months prior to inclusion
Presenting with moderate-to-severe pain intensity
Outpatients, aged 18 years and above