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

Primary Purpose

Painful Diabetic Neuropathy and Post Herpetic Neuralgia

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Pregabalin

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy and Post Herpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

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

Secondary Outcome Measures

Mean sleep score from patient's daily sleep interference diary

Change from baseline in mean sleep score from patient's daily sleep interference diary

Mean anxiety score from patient's daily anxiety diary

Adverse events

Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score

Median time to pain response profile

CGIC and PGIC

Change from baseline in EuroQOL (as measures by EQ-5D)

Change from baseline in mean anxiety score from patient's daily anxiety diary

Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score

Course of mean pain score of patient's daily pain diary (NRS)

Full Information

NCT ID

NCT00629681

First Posted

February 26, 2008

Last Updated

January 21, 2021

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00629681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Neuropathy and Post Herpetic Neuralgia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

217 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

Baseline to Week 4

Secondary Outcome Measure Information:

Title

Mean sleep score from patient's daily sleep interference diary

Time Frame

14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28

Title

Change from baseline in mean sleep score from patient's daily sleep interference diary

Time Frame

End of treatment

Title

Mean anxiety score from patient's daily anxiety diary

Time Frame

14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28

Title

Adverse events

Time Frame

14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28

Title

Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score

Time Frame

End of treatment

Title

Median time to pain response profile

Time Frame

Over the first week

Title

CGIC and PGIC

Time Frame

End of treatment

Title

Change from baseline in EuroQOL (as measures by EQ-5D)

Time Frame

End of treatment

Title

Change from baseline in mean anxiety score from patient's daily anxiety diary

Time Frame

End of treatment

Title

Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score

Time Frame

End of treatment

Title

Course of mean pain score of patient's daily pain diary (NRS)

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Aachen

ZIP/Postal Code

52064

Country

Germany

Facility Name

Pfizer Investigational Site

City

Albstadt

ZIP/Postal Code

72458

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

10435

Country

Germany

Facility Name

Pfizer Investigational Site

City

Berlin

ZIP/Postal Code

13053

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bielefeld

ZIP/Postal Code

33604

Country

Germany

Facility Name

Pfizer Investigational Site

City

Celle

ZIP/Postal Code

29221

Country

Germany

Facility Name

Pfizer Investigational Site

City

Deggingen

ZIP/Postal Code

73326

Country

Germany

Facility Name

Pfizer Investigational Site

City

Duisburg

ZIP/Postal Code

47051

Country

Germany

Facility Name

Pfizer Investigational Site

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Pfizer Investigational Site

City

Erfurt

ZIP/Postal Code

99089

Country

Germany

Facility Name

Pfizer Investigational Site

City

Frankfurt

ZIP/Postal Code

60311

Country

Germany

Facility Name

Pfizer Investigational Site

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Pfizer Investigational Site

City

Goeppingen

ZIP/Postal Code

73033

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

21073

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

22149

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hemsbach

ZIP/Postal Code

69502

Country

Germany

Facility Name

Pfizer Investigational Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Pfizer Investigational Site

City

Holle

ZIP/Postal Code

31188

Country

Germany

Facility Name

Pfizer Investigational Site

City

Itzehoe

ZIP/Postal Code

25524

Country

Germany

Facility Name

Pfizer Investigational Site

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Pfizer Investigational Site

City

Karlsruhe

ZIP/Postal Code

76199

Country

Germany

Facility Name

Pfizer Investigational Site

City

Katzhuette

ZIP/Postal Code

98746

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leer

ZIP/Postal Code

26789

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Limburgerhof

ZIP/Postal Code

67117

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ludwigshafen

ZIP/Postal Code

67061

Country

Germany

Facility Name

Pfizer Investigational Site

City

Ludwigshafen

ZIP/Postal Code

67069

Country

Germany

Facility Name

Pfizer Investigational Site

City

Luebeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Pfizer Investigational Site

City

Luenen

ZIP/Postal Code

44534

Country

Germany

Facility Name

Pfizer Investigational Site

City

Mainz

ZIP/Postal Code

55116

Country

Germany

Facility Name

Pfizer Investigational Site

City

Marl

ZIP/Postal Code

45768

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenchen

ZIP/Postal Code

81479

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenster

ZIP/Postal Code

48129

Country

Germany

Facility Name

Pfizer Investigational Site

City

Osnabrueck

ZIP/Postal Code

49078

Country

Germany

Facility Name

Pfizer Investigational Site

City

Recklinghausen

ZIP/Postal Code

45657

Country

Germany

Facility Name

Pfizer Investigational Site

City

Senftenberg

ZIP/Postal Code

01968

Country

Germany

Facility Name

Pfizer Investigational Site

City

Sinsheim

ZIP/Postal Code

74889

Country

Germany

Facility Name

Pfizer Investigational Site

City

Surwold

ZIP/Postal Code

26903

Country

Germany

Facility Name

Pfizer Investigational Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Pfizer Investigational Site

City

Veitsbronn

ZIP/Postal Code

90587

Country

Germany

Facility Name

Pfizer Investigational Site

City

Weimar

ZIP/Postal Code

99425

Country

Germany

Facility Name

Pfizer Investigational Site

City

Wiesbaden

ZIP/Postal Code

65191

Country

Germany

Facility Name

Pfizer Investigational Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Pfizer Investigational Site

City

Zwoenitz

ZIP/Postal Code

08297

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081031&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20pregabalin%20for%20the%20treatment%20of%20diabetic%20peripheral%20neuropathy%20or%20postherpetic%20neuralgia

Description

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Learn more about this trial

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

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

Painful Diabetic Neuropathy and Post Herpetic Neuralgia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial