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

Sponsored by:	SantoSolve AS
Information provided by:	SantoSolve AS
ClinicalTrials.gov Identifier:	NCT00592098

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 II

Drug Information available for: Chlorides Strontium chloride Sr 85 Strontium chloride Sr 89 Strontium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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.

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
1: Experimental 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.
2: Placebo Comparator 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

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:	SantoSolve AS ( Thorfinn Ege )
Study ID Numbers:	SMR-1589 / 2PX-SP-01, EUDRACT no: 2006-005447-29
Study First Received:	December 29, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00592098 History of Changes
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

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on May 07, 2009