Trial · NCT00424372

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

NCT00424372, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2009-09-28

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia. Trials, record NCT00424372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424372

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
NCT number: NCT00424372
Status: Completed
Phases: Phase 3
Enrollment: 126 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Neuralgia, Postherpetic
Interventions: pregabalin
First posted: 2007-01-19
Last updated: 2021-08-27
Results first posted: 2009-09-28

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Summary of Adverse Events	52 weeks	Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.
Secondary	Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	52 weeks	Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Secondary	Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score	52 weeks	Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Secondary	Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score	52 weeks	Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Secondary	Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity	52 weeks	Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Secondary	Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale	52 weeks	Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit \<= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Summary of Adverse Events	52 weeks	Safety population: all subjects who took at least 1 dose of study medication.	subjects	NUMBER
SECONDARY	Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	52 weeks	Full Analysis Set, N = Number of subjects assessed	score on scale	MEAN
SECONDARY	Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score	52 weeks	Full Analysis Set, N = Number of subjects assessed	score on scale	MEAN
SECONDARY	Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score	52 weeks	Full Analysis Set, N = Number of subjects assessed	score on scale	MEAN
SECONDARY	Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity	52 weeks	Full Analysis Set, N = Number of subjects assessed	score on scale	MEAN
SECONDARY	Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale	52 weeks	Full Analysis Set, N = Number of subjects assessed	mm	MEAN

Source ClinicalTrials.gov

Results by group25

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Summary of Adverse Events	Pregabalin	Subjects with adverse events	124		subjects
Summary of Adverse Events	Pregabalin	Subjects with serious adverse events	14		subjects
Summary of Adverse Events	Pregabalin	Subjects with severe adverse events	5		subjects
Summary of Adverse Events	Pregabalin	Subjects discontinued due to adverse events	17		subjects
Summary of Adverse Events	Pregabalin	Dose reduced or temporary discontinuation	34		subjects
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	Pregabalin	Baseline	11.3	Standard Deviation 7.0	score on scale
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	Pregabalin	Week 52	5.1	Standard Deviation 5.6	score on scale
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	Pregabalin	Endpoint	6.7	Standard Deviation 7.1	score on scale
Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score	Pregabalin	Change from Baseline to Endpoint	-4.8	Standard Deviation 5.9	score on scale
Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score	Pregabalin	Baseline	3.4	Standard Deviation 3.1	score on scale

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pregabalin	126
Overall Study	COMPLETED	Pregabalin	95
Overall Study	NOT COMPLETED	Pregabalin	31

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Retinal haemorrhage	Eye disorders	Pregabalin	7	126
other	Visual acuity reduced	Eye disorders	Pregabalin	7	126
other	Constipation	Gastrointestinal disorders	Pregabalin	12	126
other	Diarrhoea	Gastrointestinal disorders	Pregabalin	12	126
other	Nausea	Gastrointestinal disorders	Pregabalin	7	126
other	Oedema peripheral	General disorders	Pregabalin	22	126
other	Nasopharyngitis	Infections and infestations	Pregabalin	34	126
other	Fall	Injury, poisoning and procedural complications	Pregabalin	9	126
other	Weight increased	Investigations	Pregabalin	19	126
other	Arthralgia	Musculoskeletal and connective tissue disorders	Pregabalin	7	126

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pregabalin
Total, other adverse events	Pregabalin	98	126
Total, serious adverse events	Pregabalin	15	126

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27448285	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00424372

GET https://conductscience.org/api/trials/v1/NCT00424372/results?page=2

API reference For AI assistants