Trial · NCT00570310

Neuropathic Pain Syndrome Patient Study (MK-0000-072)

NCT00570310, Phase 1, Completed, Merck Sharp & Dohme LLC; results first posted 2010-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neuropathic Pain Syndrome Patient Study (MK-0000-072). Trials, record NCT00570310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00570310

On this page

Trial

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

Title: Neuropathic Pain Syndrome Patient Study (MK-0000-072)
NCT number: NCT00570310
Status: Completed
Phases: Phase 1
Enrollment: 104 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
Interventions: Comparator: pregabalin, Comparator: Placebo (unspecified)
First posted: 2007-12-10
Last updated: 2015-05-07
Results first posted: 2010-02-05

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Daily Evening Patient Reported Pain Intensity Scores	Baseline and 6 Weeks	Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)
Secondary	'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	6 Weeks	Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Daily Evening Patient Reported Pain Intensity Scores	Baseline and 6 Weeks	Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	6 Weeks	Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.	Days	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Daily Evening Patient Reported Pain Intensity Scores	Pregabalin	0.14	Full Range -2.00 to 4.33	Units on a Scale
Daily Evening Patient Reported Pain Intensity Scores	Placebo	1.57	Full Range -1.83 to 8.00	Units on a Scale
'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	Pregabalin	15.54	Full Range 3 to 21	Days
'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	Placebo	7.87	Full Range 3 to 21	Days

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Pregabalin	53
Overall Study	STARTED	Placebo	51
Overall Study	COMPLETED	Pregabalin	51
Overall Study	COMPLETED	Placebo	45
Overall Study	NOT COMPLETED	Pregabalin	2
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events178

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	Vertigo	Ear and labyrinth disorders	Pregabalin	3	51
other	Vertigo	Ear and labyrinth disorders	Placebo	0	53
other	Blindness	Eye disorders	Pregabalin	1	51
other	Blindness	Eye disorders	Placebo	0	53
other	Diplopia	Eye disorders	Pregabalin	1	51
other	Diplopia	Eye disorders	Placebo	0	53
other	Eye Irritation	Eye disorders	Pregabalin	0	51
other	Eye Irritation	Eye disorders	Placebo	1	53
other	Eye Pain	Eye disorders	Pregabalin	0	51
other	Eye Pain	Eye disorders	Placebo	1	53

1 to 10 of 178Source ClinicalTrials.gov

See all 178 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pregabalin
Total, all-cause mortality	Placebo
Total, other adverse events	Pregabalin	37	51
Total, other adverse events	Placebo	36	53
Total, serious adverse events	Pregabalin	0	51
Total, serious adverse events	Placebo	1	53

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21185118	RESULT

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 comparisons1

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

Comparison
Pregabalin vs Placebo: serious adverse events

Source Trial comparisons

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/NCT00570310

GET https://conductscience.org/api/trials/v1/NCT00570310/events?page=2

API reference For AI assistants