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Multicenter, open-label study to evaluate the safety of Trlleptal® in patients with neuropathic pain due to diabetic neuropathy

Multicenter, open-label study to evaluate the safety of Trlleptal® in patients with neuropathic pain due to diabetic neuropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-016-02
Enrollment
31
Registered
2002-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

experimental group Type of group
Patients will receive Trileptal® 1800 mg / day. The study will consist of two phases
An evaluation phase of up to two weeks and a treatment phase of one year. The treatment phase will consist of two periods: a four-week titration period and a 48-week maintenance period.

Sponsors

NOVARTIS BIOSCIENSES PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. Measure:Safety of Trileptal® 1800 mg / day, administered b.i.d., in patients with neuropathic pain due to diabetic neuropathy. Timepoints:day 84—

Secondary

MeasureTime frame
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. Measure:Long-term efficacy of Trileptal® 1800 mg / day, administered b.i.d., in patients with neuropathic pain due to diabetic neuropathy. Timepoints:At each visit.—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)