Trial · NCT00124306

Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

NCT00124306, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2025-10-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS). Trials, record NCT00124306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00124306

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Trial

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

Title: Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)
NCT number: NCT00124306
Status: Completed
Phases: Phase 3
Enrollment: 271 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Bladder Diseases, Interstitial Cystitis
Interventions: Amitriptyline, Placebo
First posted: 2005-07-27
Last updated: 2026-01-12
Results first posted: 2025-10-07

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Global Response Assessment (GRA)	12 Weeks	The primary efficacy analysis was based on intent to treat, comparing the proportion of responders between treatment arms on a patient reported GRA recorded at 12 weeks or study withdrawal. The 7-point GRA queried, "As compared to when you started the current study, how would you rate your overall symptoms now?" The 7 response options were markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. Participants who indicated that they were markedly or moderately improved were considered responders. Subjects who withdrew from the study for any reason and did not provide data on the primary outcome were considered treatment failures, and were included in the denominator for calculation of response rates.
Secondary	Changes in Quality of Life Measures From Baseline to 12 Weeks	Baseline and 12 Weeks	A number of secondary outcomes \[as detailed in the Baseline Measures section\] were assessed throughout the study. These outcomes include pain, urgency and frequency on 0 to 10-point Likert scales, a 24-hour voiding diary, the Health Status Questionnaire for Quality of Life (SF-36), the Hospital Anxiety and Depression Scale, and the Female Sexual Function Index or International Index of Erectile Function. When applicable, additional analyses of the symptom outcomes may include evaluation of secondary response rates defined by specific changes in symptoms. Associations between changes from baseline in secondary outcomes and GRA will be used to supplement the primary endpoint analysis, and to evaluate the validity of the symptom scales for assessing change.
Secondary	Change in Urinary Symptoms Measures	Baseline and 12 weeks	The O'Leary-Sant Interstitial Cystitis Symptom and Problem Indices, and the University of Wisconsin Interstitial Cystitis Symptom Inventory The IC Symptom Index is a 4-question survey w/ a severity scale from min.0(not at all) to max.5(always). The IC Problem Index is a 4-question survey with a severity scale ranging from min.0 (no problem) to max.4 (big problem). Higher subscale responses for each index indicate more severe symptoms. A sub-set of the University of Wisconsin Symptom Survey is designated as the Interstitial Cystitis Symptom Inventory w/ questions ranging from 0(not at all) to 6(a lot). Pts. reported symptoms the day of assessment. Scores ranged from 0 to 42. A higher score indicates more severe symptoms. Symptoms include: bladder pain; bladder discomfort; getting up at night to go to the bathroom; going to the bathroom frequently during the day; urgency to urinate; difficulty sleeping because of bladder problems; and burning sensation in the bladder.
Secondary	Adherence to Study Drug and Urinary Educational/Behavioral Program (EBMP Educational/Behavioral Modification Program)	12 weeks	Adherence to protocol treatment, to study drug and EBMP, at 6 weeks was assessed in 4 categories of 1) symptom management, 2) fluid management, 3) diet modification and 4) bladder training. For each of these EBMP categories adherence was defined as the overall percentage of participants who reported adhering to each component of the EBMP at each telephone contact or clinic visit. Subjects were classified into 3 groups based on the maximum dose obtained at 6 and 12 weeks as shown in the Outcome Measure Data Table below.
Secondary	Change in Nighttime Voiding From Baseline to 12 Weeks	Baseline and 12 weeks	Baseline nighttime \[sleep period\] voiding frequency was collected by participant report on a Voiding Diary with entries for each void in a 24-hour period. Each void entry included the question: "Did this void occur during your intended sleep period?" Responses: 1=Yes, 0=No. The sum was totaled for "Yes" entries in response to this question.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Global Response Assessment (GRA)	12 Weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Quality of Life Measures From Baseline to 12 Weeks	Baseline and 12 Weeks		Change in score baseline to 12 weeks	MEAN
SECONDARY	Change in Urinary Symptoms Measures	Baseline and 12 weeks	Change between the Baseline and 12-week time points is reported for each measure.	Change in score baseline to 12 weeks	MEAN
SECONDARY	Adherence to Study Drug and Urinary Educational/Behavioral Program (EBMP Educational/Behavioral Modification Program)	12 weeks	Consistent with intent to treat analytic strategies participants who did not provide data at 12 weeks, including 24 (18%) on amitriptyline and 17 (13%) on placebo, were considered treatment non-responders.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Nighttime Voiding From Baseline to 12 Weeks	Baseline and 12 weeks	Changes in nighttime voids from baseline to 12 weeks were reported by treatment arm for those with available data at those points. Nighttime \[sleep period\] voiding frequency was collected by participant report on a Voiding Diary with entries for each void in a 24-hour period. Each void entry included the question: Did this void occur during your intended sleep period? Responses: 1=Yes, 0=No. The sum was totaled for Yes entries in response to this question.	Change in voiding events	MEAN

Source ClinicalTrials.gov

Results by group26

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

Outcome	Group	Category	Value	Spread	Units
Global Response Assessment (GRA)	1 - Active Comparator	Marked/moderate improvement	74		Participants
Global Response Assessment (GRA)	2 - Placebo Comparator	Marked/moderate improvement	61		Participants
Global Response Assessment (GRA)	1 - Active Comparator	Slight improvement, same or worse	61		Participants
Global Response Assessment (GRA)	2 - Placebo Comparator	Slight improvement, same or worse	75		Participants
Changes in Quality of Life Measures From Baseline to 12 Weeks	1 - Active Comparator	Pain score	-2.6	Standard Deviation 2.5	Change in score baseline to 12 weeks
Changes in Quality of Life Measures From Baseline to 12 Weeks	2 - Placebo Comparator	Pain score	-2.3	Standard Deviation 2.4	Change in score baseline to 12 weeks
Changes in Quality of Life Measures From Baseline to 12 Weeks	1 - Active Comparator	Urgency	-3.0	Standard Deviation 2.5	Change in score baseline to 12 weeks
Changes in Quality of Life Measures From Baseline to 12 Weeks	2 - Placebo Comparator	Urgency	-2.5	Standard Deviation 2.6	Change in score baseline to 12 weeks
Changes in Quality of Life Measures From Baseline to 12 Weeks	1 - Active Comparator	Frequency	-3.5	Standard Deviation 2.3	Change in score baseline to 12 weeks
Changes in Quality of Life Measures From Baseline to 12 Weeks	2 - Placebo Comparator	Frequency	-2.6	Standard Deviation 2.5	Change in score baseline to 12 weeks

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	1 - Active Comparator	135
Overall Study	STARTED	2 - Placebo Comparator	136
Overall Study	COMPLETED	1 - Active Comparator	112
Overall Study	COMPLETED	2 - Placebo Comparator	119
Overall Study	NOT COMPLETED	1 - Active Comparator	23
Overall Study	NOT COMPLETED	2 - Placebo Comparator	17

Source ClinicalTrials.gov

Adverse events30

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	Dermatology/skin	Skin and subcutaneous tissue disorders	1 - Amitriptyline	9	135	9
other	Dermatology/skin	Skin and subcutaneous tissue disorders	2 - Placebo	10	136	10
other	Gastrointestinal	General disorders	1 - Amitriptyline	57	135	57
other	Gastrointestinal	General disorders	2 - Placebo	32	136	32
other	Constitutional symptoms	General disorders	1 - Amitriptyline	61	135	61
other	Constitutional symptoms	General disorders	2 - Placebo	42	136	42
other	Infection, fever	Infections and infestations	1 - Amitriptyline	9	135	9
other	Infection, fever	Infections and infestations	2 - Placebo	14	136	14
other	Musculokeletal	Musculoskeletal and connective tissue disorders	1 - Amitriptyline	7	135	7
other	Musculokeletal	Musculoskeletal and connective tissue disorders	2 - Placebo	3	136	3

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 - Amitriptyline	0	135
Total, all-cause mortality	2 - Placebo	0	136
Total, other adverse events	1 - Amitriptyline	119	135
Total, other adverse events	2 - Placebo	98	136
Total, serious adverse events	1 - Amitriptyline	2	135
Total, serious adverse events	2 - Placebo	3	136

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20303115	RESULT	PubMed
32734597	DERIVED	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 comparisons2

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

Comparison	Source
1 - Amitriptyline vs 2 - Placebo: deaths from any cause	Trial comparisons
1 - Amitriptyline 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.

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