Pregabalin vs Placebo in Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00143156

Collaborator

(none)

450

Enrollment

Locations

Duration (Months)

8.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of pregabalin administered twice a day compared to placebo in reducing pain in subjects with painful diabetic peripheral neuropathy.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies	Drug: pregabalin	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Study Start Date :

Mar 1, 2005

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

The primary efficacy parameter is the endpoint End of Week 12 weekly mean pain score derived from the pain diary. []

Secondary Outcome Measures

End of Week 12 responder rates, Brief Pain Inventory - short form, sleep interference scores, Medical Outcome Study - Sleep Scale, Hospital Anxiety and Depression Scale, Patient Global Impression of Change, Neuropathic Pain Inventory Symptom Inventory. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males or females at least 18 years of age, of any ethnic origin
Type 1 or 2 diabetes mellitus
Pain score greater than or equal to 4 on the 11-point numeric pain rating scale

Exclusion Criteria:

Neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain.
Presence of severe pain associated with conditions other than diabetic peripheral neuropathy, that could confound the assessment or self-evaluation of pain due to DPN.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Tuscaloosa	Alabama	United States	35406
2	Pfizer Investigational Site	Phoenix	Arizona	United States	85023
3	Pfizer Investigational Site	Little Rock	Arkansas	United States	72205
4	Pfizer Investigational Site	La Mesa	California	United States	91942
5	Pfizer Investigational Site	Los Gatos	California	United States	95032-3739
6	Pfizer Investigational Site	Northridge	California	United States	91325
7	Pfizer Investigational Site	Tustin	California	United States	92780
8	Pfizer Investigational Site	Walnut Creek	California	United States	94598
9	Pfizer Investigational Site	Boulder	Colorado	United States	80304
10	Pfizer Investigational Site	Wheat Ridge	Colorado	United States	80033
11	Pfizer Investigational Site	New Haven	Connecticut	United States	06510
12	Pfizer Investigational Site	Clearwater	Florida	United States	33761
13	Pfizer Investigational Site	Hollywood	Florida	United States	33021
14	Pfizer Investigational Site	Ocala	Florida	United States	34471
15	Pfizer Investigational Site	Tampa	Florida	United States	33606
16	Pfizer Investigational Site	West Palm Beach	Florida	United States	33407-2450
17	Pfizer Investigational Site	Atlanta	Georgia	United States	30303
18	Pfizer Investigational Site	Atlanta	Georgia	United States	30309
19	Pfizer Investigational Site	Atlanta	Georgia	United States	30327
20	Pfizer Investigational Site	Decatur	Georgia	United States	30033
21	Pfizer Investigational Site	Chicago	Illinois	United States	60610
22	Pfizer Investigational Site	Chicago	Illinois	United States	60612
23	Pfizer Investigational Site	Peoria	Illinois	United States	61602
24	Pfizer Investigational Site	Springfield	Illinois	United States	62704
25	Pfizer Investigational Site	Indianapolis	Indiana	United States	46250
26	Pfizer Investigational Site	Lexington	Kentucky	United States	40503
27	Pfizer Investigational Site	Baltimore	Maryland	United States	21204
28	Pfizer Investigational Site	Boston	Massachusetts	United States	02115
29	Pfizer Investigational Site	Boston	Massachusetts	United States	02215
30	Pfizer Investigational Site	Springfield	Massachusetts	United States	01104
31	Pfizer Investigational Site	Jackson	Mississippi	United States	39202
32	Pfizer Investigational Site	Tupelo	Mississippi	United States	38803-4087
33	Pfizer Investigational Site	Jefferson City	Missouri	United States	65109
34	Pfizer Investigational Site	Saint Louis	Missouri	United States	63141
35	Pfizer Investigational Site	Omaha	Nebraska	United States	68116-6465
36	Pfizer Investigational Site	Englewood	New Jersey	United States	07631
37	Pfizer Investigational Site	Shrewsbury	New Jersey	United States	07702
38	Pfizer Investigational Site	New Hyde Park	New York	United States	11042
39	Pfizer Investigational Site	New York	New York	United States	10022-1009
40	Pfizer Investigational Site	New York	New York	United States	10032
41	Pfizer Investigational Site	Kettering	Ohio	United States	45429
42	Pfizer Investigational Site	Toledo	Ohio	United States	43623
43	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74104-5428
44	Pfizer Investigational Site	Warwick	Rhode Island	United States	02886
45	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
46	Pfizer Investigational Site	Dallas	Texas	United States	75390-8858
47	Pfizer Investigational Site	Frisco	Texas	United States	75034
48	Pfizer Investigational Site	Houston	Texas	United States	77030
49	Pfizer Investigational Site	San Antonio	Texas	United States	78207
50	Pfizer Investigational Site	San Antonio	Texas	United States	78229
51	Pfizer Investigational Site	Salt Lake City	Utah	United States	84108
52	Pfizer Investigational Site	Burlington	Vermont	United States	05401
53	Pfizer Investigational Site	Charlottesville	Virginia	United States	22908
54	Pfizer Investigational Site	Ponce		Puerto Rico	00716