Status:
TERMINATED
Safety Study of TAK-128 in Subjects With Diabetic Peripheral Neuropathy
Lead Sponsor:
Takeda
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety of TAK-128, once daily (QD), for treatment of diabetic peripheral neuropathy
Detailed Description
Polyneuropathy is a frequent complication of diabetes; it affects most individuals after prolonged hyperglycemia, and diabetic neuropathy is very common in the developed world. Chronic, insidious, dis...
Eligibility Criteria
Inclusion
- Has successfully completed protocol 01-04-TL-128-003.
- Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception.
- Must be in good health at Enrollment, as determined by a physician at the Month 6 Visit of Protocol 01-04-TL-128-003 (ie, via medical history and physical examination).
- Has clinical laboratory evaluations within the normal reference range for the testing laboratory, unless the results are deemed not clinically significant by the investigator or sponsor, at the Month 6 Visit of Protocol 01-04-TL-128-003.
- Has a creatinine level less than or equal to 2 mg/dL or 176.8 umol/L.
- The subject is willing to follow an American Diabetes Association or similar recommended dietary regimen.
Exclusion
- Has developed other neuropathies due to causes other than diabetes such as alcohol abuse liver or renal disease, uremia, toxic exposure, genetic factors, inflammatory demyelinating diseases, monoclonal gammopathies; or endocrine, metabolic or nutritional disorders (included treated or untreated pernicious anemia).
- Has a systolic blood pressure greater than 160 mm HG or diastolic blood pressure is greater than 95 mm HG.
- The subject has an alanine aminotransferase level of greater than 1.5 times the upper limit of normal, active liver disease, or jaundice.
- Has a significant, actively treated or unstable pulmonary, cardiovascular, gastrointestinal, hepatic, hematologic, musculoskeletal, or endocrine (other than diabetes mellitus or stably treated hypothyroidism) disease.
- Cannot use any of the following prescription medications throughout the duration of the study, including:
- Lipoic acid.
- Linolenic acid (primrose oil).
- Inositol.
- Topiramate.
- Acetyl-L-Carnitine.
- Nerve growth factors.
- Capsaicin.
- Has any other serious disease or condition at the Month 6 Visit of Protocol 01-04-TL-128-003 or at the Baseline/Rollover Visit that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00756041
Start Date
September 1 2005
End Date
September 1 2006
Last Update
February 28 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.