Trial · NCT00371033

Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

NCT00371033, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2025-09-22

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). Trials, record NCT00371033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00371033

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Trial

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

Title: Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
NCT number: NCT00371033
Status: Completed
Phases: Phase 3
Enrollment: 324 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Interventions: Pregabalin, Placebo
First posted: 2006-09-01
Last updated: 2025-09-22
Results first posted: 2025-09-22

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Decrease in the NIH-CPSI Total Score by at Least 6 Points	Baseline and 6 weeks	Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.
Secondary	Subscales of the NIH-CPSI	6 weeks	The National Institutes of Health -Chronic Prostatitis Symptom Index (NIH-CPSI) measures the 3 key domains of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS): pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A higher score indicates more severe symptoms. A 6-point decrease in NIHCPSI score has been shown to be clinically perceptible in previous clinical trials of men with CP/CPPS.
Secondary	Moderately or Markedly Improve on Global Response Assessment (GRA)	6 weeks	The GRA is a 7-question patient self-reported assessment that measures perception of change in symptoms (improvement, no change, or deterioration). The responses are centered at zero (no change in symptoms). Men who reported that they were moderately or markedly improved on a 7-point GRA at the end of the study were identified as treatment responders.
Secondary	Hospital Anxiety & Depression Scale	6 weeks	Hospital Anxiety and Depression Scale (HADS) (range, 0-42, with higher scores indicating greater anxiety and depression)
Secondary	McGill Pain Questionnaire	6 weeks	The McGill Pain Questionnaire (MPQ) evaluates the quality of pain as well as the intensity of pain. The McGill Pain Questionnaire ranges from 0-45 for a total pain score, and is the sum of a sensory subscore of 0-33 and affective subscore of 0-12. Higher scores indicate greater pain.
Secondary	Medical Outcomes Study Short Form 12	6 weeks	Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) (range, 0-100 for the Physical \[PCS\] and Mental \[MCS\] Component Summary scores, with the mean set at 50 and higher scores indicating better quality of life)
Secondary	Sexual Health Inventory for Men	6 weeks	Sexual Health Inventory for Men (SHIM) (range, 1-25, with higher scores indicating better sexual function)

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Decrease in the NIH-CPSI Total Score by at Least 6 Points	Baseline and 6 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Subscales of the NIH-CPSI	6 weeks	The overall number of participants analyzed in the secondary outcome measures were 210 for the pregabalin arm and 103 for the placebo arm.	units on the NIH-CPSI scale	MEAN
SECONDARY	Moderately or Markedly Improve on Global Response Assessment (GRA)	6 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hospital Anxiety & Depression Scale	6 weeks		units on a scale	MEAN
SECONDARY	McGill Pain Questionnaire	6 weeks		units on a scale	MEAN
SECONDARY	Medical Outcomes Study Short Form 12	6 weeks		units on a scale	MEAN
SECONDARY	Sexual Health Inventory for Men	6 weeks		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Category	Value	Spread	Units
Decrease in the NIH-CPSI Total Score by at Least 6 Points	1-Pregabalin		103		Participants
Decrease in the NIH-CPSI Total Score by at Least 6 Points	2-Placebo		38		Participants
Subscales of the NIH-CPSI	1-Pregabalin	Total score	19.7	Standard Deviation 8.5	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	2-Placebo	Total score	21.6	Standard Deviation 8.9	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	1-Pregabalin	Pain domain score	9.1	Standard Deviation 3.1	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	2-Placebo	Pain domain score	10.1	Standard Deviation 4.7	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	1-Pregabalin	Urinary symptoms domain score	3.7	Standard Deviation 2.6	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	2-Placebo	Urinary symptoms domain score	4.0	Standard Deviation 2.7	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	1-Pregabalin	Quality of life domain	6.9	Standard Deviation 2.9	units on the NIH-CPSI scale
Subscales of the NIH-CPSI	2-Placebo	Quality of life domain	7.4	Standard Deviation 3.1	units on the NIH-CPSI scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	1-Pregabalin	218
Overall Study	STARTED	2-Placebo	106
Overall Study	COMPLETED	1-Pregabalin	210
Overall Study	COMPLETED	2-Placebo	103
Overall Study	NOT COMPLETED	1-Pregabalin	8
Overall Study	NOT COMPLETED	2-Placebo	3

Source ClinicalTrials.gov

Adverse events12

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	Events
other	Pain	General disorders	1-Pregabalin	38	218	38
other	Pain	General disorders	2-Placebo	35	106	38
other	Constitutional symptoms	General disorders	1-Pregabalin	53	218	53
other	Constitutional symptoms	General disorders	2-Placebo	22	106	22
other	Neurologic symptoms	Nervous system disorders	1-Pregabalin	40	218	40
other	Neurologic symptoms	Nervous system disorders	2-Placebo	20	106	20
other	Gastrointestinal disturbance	Gastrointestinal disorders	1-Pregabalin	40	218	40
other	Gastrointestinal disturbance	Gastrointestinal disorders	2-Placebo	20	106	20
other	Ocular/visual symptoms	Eye disorders	1-Pregabalin	15	218	15
other	Ocular/visual symptoms	Eye disorders	2-Placebo	3	106	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1-Pregabalin	0	218
Total, all-cause mortality	2-Placebo	0	106
Total, other adverse events	1-Pregabalin	129	218
Total, other adverse events	2-Placebo	62	106
Total, serious adverse events	1-Pregabalin	0	218
Total, serious adverse events	2-Placebo	0	106

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20876412	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK065209	Data Coordinating Center for CPCRN and ICCRN	LANDIS, J RICHARD	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2003 to 2007

Source NIH RePORTER

Trial comparisons4

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

Comparison	Source
1-Pregabalin vs 2-Placebo: Moderately or Markedly Improve on Global Response Assessment (GRA)	Trial comparisons
1-Pregabalin vs 2-Placebo: Decrease in the NIH-CPSI Total Score by at Least 6 Points	Trial comparisons
1-Pregabalin vs 2-Placebo: deaths from any cause	Trial comparisons
1-Pregabalin vs 2-Placebo: serious adverse events	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/NCT00371033

GET https://conductscience.org/api/trials/v1/NCT00371033/results?page=2

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