None listed
Conditions
Interventions
Fixed dose branch Type of group
Patients randomized to the fixed dose Branch will receive 300 mg three times a day of gabapentin for 7 weeks
Group name:Valuation Branch Type of group
Patients randomized to the Valuation Branch
they will begin the therapy with 300 mg three times a day of gabapentin, which starts with the following dosage program:
Administration will start on the night of V2 (Day = 1), with a dose of 300 mg to HS (at bedtime). On Day = 2 the patient will receive 300 mg BID (once in the morning and once in the evening). Beginning with the morning of Day = 3, the patient will receive 300 mg TID (900 mg / day).
After that, the study medication should be
Sponsors
PARKE DAVIS,
Eligibility
Inclusion criteria
Inclusion criteria: • Males or non-pregnant women who are not breastfeeding who are postmenopausal or surgically sterile; women at risk of pregnancy should receive advice about appropriate contraceptive methods (including barrier or hormonal methods) and have a confirmed negative pregnancy test; • Diabetes mellitus diagnosis (type I or II); hemoglobin A levels, c of 40mm on the visual analog scale of the SF-MPQ; • For the start of treatment, patients must have completed at least 4 days in the diaries of pain and interference with sleep during the 7 days prior to the treatment phase, and have an average rating of> 4 during the last 7 days in the pain journal; • Patients who receive a stable dose of benzodiazepine at bedtime (without any postoperative change during the last 30 days or during the study) should have an average score of ^ in the sleep interference log during the 7 days before starting the study. treatment. • Be able to understand and cooperate with the study procedures; Y • Have signed a written informed consent before entering the study.
Exclusion criteria
Exclusion criteria: • Previous treatment with gabapentin; • Creatinine clearance of 60 mL / min); • Patients for whom a change from oral medication for diabetes to insulin is expected during the study; • Severe hepatic, respiratory or hematological diseases, unstable cardiovascular disease or symptomatic peripheral vascular disease (patients with this latter disease may be included if, in addition to peripheral vascular disease and the pain that may be associated with it, they have clearly distinguishable pain caused by peripheral diabetic neuropathy); • Neurological disorders not related to diabetic neuropathy that, in the opinion of the researcher, could confuse the assessment of pain related to neuropathy; • Other possible causes of painful neuropathy such as the known existence of a history of pernicious anemia, untreated hypothyroidism, a history of chronic hepatitis B, a new diagnosis of hepatitis B or hepatitis C during the last 3 months or HIV; • Skin conditions in the area affected by the neuropathy that could alter the sensation; • The use of analgesics other than acetaminophen (maximum daily total dose <2 g) or aspirin (maximum daily dose <325 mg), antidepressants other than serotonin incorporation inhibitors, benzodiazepines except a stable dose at bedtime, anticonvulsants, neuroleptics or any concomitant medication during the past 7 days that could alter the effectiveness of the study medication (see Section 5.3 for the list); • Other severe pain that could confuse evaluation or self-assessment of pain due to diabetic neuropathy; • The administration of any experimental drug within 30 days prior to the selective phase; • Amputations other than toes; • Abuse of illicit drugs or alcohol within the last year; or • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, could compromise participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary parameter of effectiveness will be the percentage reduction in the mean weekly pain rating (Likert scale) taken from the pain diary. Secondary efficacy parameters will be the McGill Short Pain Questionnaire, the interference rating with the mean weekly sleep taken from the sleep diary, and the Clinical and Patient Global Change Impression (CGIC and PGIC). Measure:Efficacy Timepoints:Before and after of administration of treatment | — |
Outcome results
None listed