A Study of the Efficacy and Safety of Pregabalin for the Treatment of Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00629681

Collaborator

(none)

217

Enrollment

Locations

Arm

Duration (Months)

4.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)

Condition or Disease	Intervention/Treatment	Phase
Painful Diabetic Neuropathy and Post Herpetic Neuralgia	Drug: Pregabalin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

217 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia

Study Start Date :

Nov 1, 2004

Actual Study Completion Date :

Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Pregabalin Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.

Arm

Intervention/Treatment

Experimental: 1

Drug: Pregabalin

Pregabalin capsules; initial dose of 75 mg twice daily for 4 days. Dose could be increased based on individual patient's response and tolerability to 150 mg twice daily from Day 4 onwards, with a further increase to 300 mg twice daily from Day 14 onwards if needed. Total duration of treatment was 28 days.

Outcome Measures

Primary Outcome Measures

Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters [Baseline to Week 4]

Secondary Outcome Measures

Mean sleep score from patient's daily sleep interference diary [14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28]
Change from baseline in mean sleep score from patient's daily sleep interference diary [End of treatment]
Mean anxiety score from patient's daily anxiety diary [14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28]
Adverse events [14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28]
Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score [End of treatment]
Median time to pain response profile [Over the first week]
CGIC and PGIC [End of treatment]
Change from baseline in EuroQOL (as measures by EQ-5D) [End of treatment]
Change from baseline in mean anxiety score from patient's daily anxiety diary [End of treatment]
Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score [End of treatment]
Course of mean pain score of patient's daily pain diary (NRS) [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Diagnosis of DPN or PHN
Score on the Numeric Rating Scale of at least 4/10

Exclusion Criteria:

Hospitalized patients
Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Aachen	Germany	52064
2	Pfizer Investigational Site	Albstadt	Germany	72458
3	Pfizer Investigational Site	Berlin	Germany	10117
4	Pfizer Investigational Site	Berlin	Germany	10435
5	Pfizer Investigational Site	Berlin	Germany	13053
6	Pfizer Investigational Site	Bielefeld	Germany	33604
7	Pfizer Investigational Site	Celle	Germany	29221
8	Pfizer Investigational Site	Deggingen	Germany	73326
9	Pfizer Investigational Site	Duisburg	Germany	47051
10	Pfizer Investigational Site	Erbach	Germany	64711
11	Pfizer Investigational Site	Erfurt	Germany	99089
12	Pfizer Investigational Site	Frankfurt	Germany	60311
13	Pfizer Investigational Site	Gera	Germany	07548
14	Pfizer Investigational Site	Goeppingen	Germany	73033
15	Pfizer Investigational Site	Hamburg	Germany	21073
16	Pfizer Investigational Site	Hamburg	Germany	22149
17	Pfizer Investigational Site	Hamburg	Germany	22607
18	Pfizer Investigational Site	Hemsbach	Germany	69502
19	Pfizer Investigational Site	Hildesheim	Germany	31134
20	Pfizer Investigational Site	Holle	Germany	31188
21	Pfizer Investigational Site	Itzehoe	Germany	25524
22	Pfizer Investigational Site	Karlsruhe	Germany	76133
23	Pfizer Investigational Site	Karlsruhe	Germany	76199
24	Pfizer Investigational Site	Katzhuette	Germany	98746
25	Pfizer Investigational Site	Leer	Germany	26789
26	Pfizer Investigational Site	Leipzig	Germany	04103
27	Pfizer Investigational Site	Limburgerhof	Germany	67117
28	Pfizer Investigational Site	Ludwigshafen	Germany	67061
29	Pfizer Investigational Site	Ludwigshafen	Germany	67069
30	Pfizer Investigational Site	Luebeck	Germany	23552
31	Pfizer Investigational Site	Luenen	Germany	44534
32	Pfizer Investigational Site	Mainz	Germany	55116
33	Pfizer Investigational Site	Marl	Germany	45768
34	Pfizer Investigational Site	Muenchen	Germany	81479
35	Pfizer Investigational Site	Muenster	Germany	48129
36	Pfizer Investigational Site	Osnabrueck	Germany	49078
37	Pfizer Investigational Site	Recklinghausen	Germany	45657
38	Pfizer Investigational Site	Senftenberg	Germany	01968
39	Pfizer Investigational Site	Sinsheim	Germany	74889
40	Pfizer Investigational Site	Surwold	Germany	26903
41	Pfizer Investigational Site	Unterhaching	Germany	82008
42	Pfizer Investigational Site	Veitsbronn	Germany	90587
43	Pfizer Investigational Site	Weimar	Germany	99425
44	Pfizer Investigational Site	Wiesbaden	Germany	65191
45	Pfizer Investigational Site	Witten	Germany	58452
46	Pfizer Investigational Site	Zwoenitz	Germany	08297