A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
NCT00156078
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Diagnosis of Type 1 or 2 diabetes mellitus.
- Diagnosis of painful DPN for at least 12 months but less than 5 years in duration.
- Neurologic Disorders unrelated to diabetic neuropathy that may confuse or confound the
assessment of neuropathic pain.
- Presence of any severe pain associated with conditions other than DPN that may confuse
or confound the assessment of neuropathic pain.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Nagoya, Aichi
- Date-shi, Fukushima
- Nihonmatsu, Fukushima
- Shirakawa-shi, Fukushima
- Sukagawa, Fukushima
- Kamakura, Kanagawa
- Yokohama, Kanagawa
- Sendai, Miyagi
- Matsumoto, Nagano
- Ueda, Nagano
- Beppu, Oita
- Yamada, Okayama
- Naha, Okinawa
- Tomishiro, Okinawa
- Urazoe, Okinawa
- Hirano-ku, Osaka
- Suminoe-ku, Osaka
- Sunto-gun, Shizuoka
- Oyama-shi, Tochigi
- Arakawa, Tokyo
- Bunkyo-ku, Tokyo
- Chiyoda-ku, Tokyo
- Ohta-ku, Tokyo
- Shibuya-ku, Tokyo
- Fukuoka,
- Oita,
- Tokushima,
- Nagoya, Aichi
- Chikushino, Fukuoka
- Kasuga, Fukuoka
- Date-shi, Fukushima
- Nihonmatsu, Fukushima
- Shirakawa-shi, Fukushima
- Sukagawa, Fukushima
- Kure, Hiroshima
- Chitose, Hokkaido
- Ebetu, Hokkaido
- Sapporo, Hokkaido
- Sapporo, Hokkaiido
- Kobe, Hyogo
- Inashiki, Ibaraki
- Kamakura, Kanagawa
- Yokohama, Kanagawa
- Yatsushiro, Kumamoto
- Sendai, Miyagi
- Matsumoto, Nagano
- Ueda, Nagano
- Beppu, Oita
- Yamada, Okayama
- Naha, Okinawa
- Tomishiro, Okinawa
- Urazoe, Okinawa
- Higashiosaka, Osaka
- Hirano-ku, Osaka
- Kishiwada, Osaka
- Suminoe-ku, Osaka
- Sunto-gun, Shizuoka
- Oyama-shi, Tochigi
- Utsunomiya, Tochigi
- Arakawa, Tokyo
- Bunkyo-ku, Tokyo
- Chiyoda-ku, Tokyo
- Chuo-ku, Tokyo
- Minato-ku, Tokyo
- Nishitokyo, Tokyo
- Ohta-ku, Tokyo
- Shibuya-ku, Tokyo
- Fukuoka,
- Kumamoto,
- Nagasaki,
- Niigata,
- Oita,
- Okayama,
- Saga,
- Saitama,
- Tokushima,
- Buenos Aires,
- Belo Horizonte, MG
- Niteroi, RJ
- Providencia, Santiago
- Valparaiso, V Region
- Medellin, Antioquia
- Bogotá, Cundinamarca
- Quito, Pichincha
- Jakarta Pusat,
- Surabaya,
- Amman,
- Pusan,
- Seoul,
- Beirut,
- Kuala Lumpur,
- Monterrey, Nuevo Leon
- Mexico Df,
- San Luis Potosi,
- Espana, Manila
- Quezon City,
- Riyadh,
- Singapore,
- Gueishan Shiang, Taoyan Hsien
- Taipei,
- Khet Rajathevee, Bangkok
- Muang, Chiang Mai
- Capa, Istanbul
- Ankara,
- Istanbul,
- Izmir,
- Mersin,
- Abu Dhabi,
- El Hatillo, Caracas-Estado Miranda
- Caracas, Distrito Capital
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN) | |||
Official Title ICMJE | A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN). | |||
Brief Summary | A study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (DPN). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Diabetic Neuropathy, Painful | |||
Intervention ICMJE | Drug: pregabalin | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 450 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | May 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Brazil, Chile, Colombia, Ecuador, Indonesia, Jordan, Korea, Republic of, Lebanon, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00156078 | |||
Other Study ID Numbers ICMJE | A0081030 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |