Expired Study
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Clovis, California 93611


Purpose:

Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.


Criteria:

Inclusion Criteria: - Male or female of non-childbearing potential - Pain present for more than 3 months after healing of herpes zoster skin rash - VAS score of >=40mm at screening and baseline visits Exclusion Criteria: - Patients with pain conditions which might impair the assessment of postherpetic neuralgia - Skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia - History or diagnosis of DSM IV major depressive disorder


Study is Available At:


Original ID:

B0261002


NCT ID:

NCT00599638


Secondary ID:


Study Acronym:


Brief Title:

A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia


Official Title:

A Two Week Double-Blind Placebo-Controlled Crossover Study To Compare The Efficacy And Safety Of A Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Patients With Post-Herpetic Neuralgia


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

130


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:March 2008
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:October 2009
Last Changed Date:October 7, 2009
First Received Date:January 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary endpoint will be the 11-point Daily Pain Rating Scale. This will be collected daily by means of a telephone interactive voice recognition (IVR) system.
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Secondary efficacy endpoints will consist of the Patient Global Assessment of Change (PGIC), and the Neuropathic Pain Symptom Inventory (NPSI).
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety endpoints will consist of adverse event reports, vital signs (blood pressure and heart rate) sitting and standing, 12-lead ECG, and laboratory safety tests.
Time Frame:2 weeks
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:pregabalin
Description:75mg bid titrating to 150mg bid on day 4
Arm Name:1
Intervention Type:Drug
Name:pregabalin/PF-00489791
Description:Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4
Arm Name:2
Intervention Type:Drug
Name:Placebo
Description:Placebo
Arm Name:3

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Study Arm Type:Experimental
Arm Name:2
Study Arm Type:Placebo Comparator
Arm Name:3

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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