Trials Sponsors Conditions Drugs Pricing

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

Pain relief
After 1 month treatment

Secondary Outcomes (1)

Pain intensity measured daily on numeric rating scales
During treatment periods

Interventions

Levetiracetam (drug)Drug

The starting dose of levetiracetam was 500 mg/day and the dose was increased with 500 mg every other day to 6 tablets of 500 mg (Keppra, UCB, Belgium), divided into two doses daily corresponding to 3000 mg/day. The dose was kept at this level throughout the remaining treatment period - 4 weeks total. Six placebo tablets with identical appearance were dosed similarly to levetiracetam in the placebo phase.

Also known as: Keppra, Levetiracetam

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Symptoms characteristic for postmastectomy pain syndrome with a duration of more than 3 months and at least 6 months after the operation.
Neuropathic pain diagnose confirmed by abnormities in the neurological investigation and/or psychophysical sensory testing

Sponsors & Collaborators

Odense University Hospital
Otherlead

Study Sites (1)

Department of neurology, Odense Universityhospital

Odense, Fyn, 5000, Denmark

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LevetiracetamPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic Chemicals

Study Officials

Ole J Vilholm, MD
Odense University Hospital
STUDY DIRECTOR
Søren H Sindrup, Professor MD
Odense University Hospital
PRINCIPAL INVESTIGATOR
Søren Cold, MD
Department of oncology, Odense University Hospital, Denmark
STUDY CHAIR
Lars Rasmussen, MD
Department of surgery, Odense University Hospital, Denmark
STUDY CHAIR

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

December 5, 2005

First Posted

December 6, 2005

Study Start

March 2004

Date type not reported

This date has not been verified as actual or estimated.

The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations