NCT00592098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
Last Updated

January 11, 2008

Status Verified

December 1, 2007

Enrollment Period

4 months

First QC Date

December 29, 2007

Last Update Submit

January 10, 2008

Conditions

Amputation StumpsPain

Keywords

Lower limb amputation at least 6 months prior to inclusionPresenting with moderate-to-severe pain intensityOutpatients, aged 18 years and above

Outcome Measures

Primary Outcomes (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).

    24 hours

Secondary Outcomes (9)

  • • Worst Pain Intensity (WPI)

    24 hours

  • • Pain relief

    Weekly

  • • Sleep disturbance

    24 hours

  • • Use of rescue medication

    Daily

  • • Patient Global Impression of Change (PGIC)

    Weekly

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

2PX

Drug: Strontium chloride hexahydrate

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Strontium chloride hexahydrateDRUG

Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.

Also known as: 2PX
1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smerud Investigator site 1

Oslo, Norway

Location

MeSH Terms

Conditions

Pain

Interventions

strontium chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Knut T Smerud, MSc

    Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 29, 2007

First Posted

January 11, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 11, 2008

Record last verified: 2007-12

Locations

NO(1)