Multicenter, open-label study to evaluate the safety ofTrlleptal® in patients with neuropathic pain due to diabeticneuropathy

Not Applicable

• Conditions: -E109 Insulin-dependent diabetes mellitus, without complications; Insulin-dependent diabetes mellitus, without complications; E109

• Registration Number: PER-016-02
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-02-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients will be ambulatory, men or women 18 years of age or older.
• Patients must have an established diagnosis of diabetes mellitus (type I or II).
• Patients must have had neuropathic pain due to diabetic neuropathy for at least 6 months.
• Hemoglobin Aic levels must be 11% or lower.
• Serum sodium levels should be at least 135mmoI / L.

Exclusion Criteria

• Patients with a clinically significant psychiatric diagnosis that may impede their reliable participation in the study.
• Patients with known or suspected chronic infectious diseases including HIV, hepatitis B, or hepatitis C.
• Patients with epilepsy.
• Patients with an ECG with significant abnormalities ..
• Patients with a history of renal failure documented by creatinine clearance <30 mL / min.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Monitoring and recording of adverse events and adverse events of immediate reporting, regular monitoring of hematology, serum biochemistry and urinalysis, as well as the measurement of vital signs and performance in physical, neurological examinations and the sensorium, and the ECG.<br>Measure:Safety of Trileptal® 1800 mg / day, administered b.i.d., in patients with neuropathic pain due to diabetic neuropathy.<br>Timepoints:day 84<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Las evaluaciones de eficacia consistiran en una clasificacion de la severidad del dolor en una escala analogica visual de 100 unidades (VAS). La clasificacion sera realizada por el paciente en cada visita y se referira a la intensidad del dolor durante la semana previa a la visita.<br>Measure:Long-term efficacy of Trileptal® 1800 mg / day, administered b.i.d., in patients with neuropathic pain due to diabetic neuropathy.<br>Timepoints:At each visit.<br>