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

This study has been completed.
Sponsor:
Information provided by:
SantoSolve AS
ClinicalTrials.gov Identifier:
NCT00592098
First received: December 29, 2007
Last updated: January 10, 2008
Last verified: December 2007
  Purpose

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 Intervention Phase
Amputation Stumps
Pain
Drug: Strontium chloride hexahydrate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by SantoSolve AS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Worst Pain Intensity (WPI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • • Pain relief [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • • Sleep disturbance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • • Use of rescue medication [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • • Patient Global Impression of Change (PGIC) [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • • Prosthesis bothersomeness [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • • Quality of life assessment [ Time Frame: Q 14 days ] [ Designated as safety issue: No ]
  • Local skin irritability [ Time Frame: Q 14 days ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Q 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: August 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 29, 2007
Last Updated: January 10, 2008
Health Authority: Norway: Medicines Control Agency

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

ClinicalTrials.gov processed this record on August 28, 2014