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A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Peripheral Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at
Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to
randomization.

- Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased
sensation in the feet or decreased/absent ankle jerk/ reflexes.

- Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.

- A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy
on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10
meaning worst pain at Screening.

- Be willing to stop all pain medications for diabetic peripheral neuropathy except for
the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications
between Screening and Baseline and not use prohibited pain medications throughout the
duration of the study except as permitted by the study guidelines.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Painful neuropathies other than diabetic peripheral neuropathy.

- Other types of diabetic neuropathies.

- Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of
CTS in the one year prior to Screening are not eligible for participation.

- Patients with fibromyalgia, regional pain caused by lumbar or cervical compression
with radiculopathy or other moderate to severe pain.

- Patients with a present (current) history of sciatica are not eligible for
participation.

- The presence of pain conditions that cannot be distinguished from diabetic peripheral
neuropathy such as peripheral vascular disease.

- Amputations dues to diabetes.

- Patient with any clinically significant medical condition or laboratory abnormalities.

- History, diagnosis, or signs and symptoms of clinically significant neurological
diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).

- History, diagnosis, or signs and symptoms of clinically significant psychiatric
diseases (such as bipolar disorder or schizophrenia).

- History of known alcohol, analgesic or drug abuse within 2 years of Screening.

- Pregnant women, lactating mothers, women suspected of being pregnant, and women who
wish to be pregnant during the course of clinical study.

NCT01087203
Pfizer
Terminated
A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

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[email protected]

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