Trial · NCT03397771

DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence

NCT03397771, Phase 1, Phase 2, Completed, Ixaltis SA; results first posted 2020-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence. Trials, record NCT03397771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03397771

On this page

Trial

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

Title: DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence
NCT number: NCT03397771
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 84 participants, actual
Lead sponsor: Ixaltis SA
Conditions: Urinary Incontinence
Interventions: Litoxetine, placebo
First posted: 2018-01-12
Last updated: 2020-06-11
Results first posted: 2020-06-11

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Subjects With Treatment-Emergent Adverse Events	from randomisation to treatment completion, an average of 8 weeks	AE, SAE, AE of special interest occuring after the start of treatment (LTX or PBP)
Secondary	Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence	change in number of incontinence episodes from baseline to week 8 of treatment	number of incontinence episodes measured by the use of a bladder diary; change from baseline to week 8 (the higher the number the worse the incontinence severity; minimum value would be zero, there is no limit for maximum value)

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	Number of Subjects With Treatment-Emergent Adverse Events	from randomisation to treatment completion, an average of 8 weeks	The analysis of TEAE was conducted on the Safety Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence	change in number of incontinence episodes from baseline to week 8 of treatment	ITT	incontinence events	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
Number of Subjects With Treatment-Emergent Adverse Events	Litoxetine Oral Capsules	20		Participants
Number of Subjects With Treatment-Emergent Adverse Events	Placebo Oral Capsules	10		Participants
Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence	Litoxetine Oral Capsules	-2.05	95% Confidence Interval -2.57 to -1.54	incontinence events
Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence	Placebo Oral Capsules	-1.20	95% Confidence Interval -1.81 to -0.58	incontinence events

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Litoxetine Oral Capsules	53
Overall Study	STARTED	Placebo Oral Capsules	29
Overall Study	COMPLETED	Litoxetine Oral Capsules	45
Overall Study	COMPLETED	Placebo Oral Capsules	22
Overall Study	NOT COMPLETED	Litoxetine Oral Capsules	8
Overall Study	NOT COMPLETED	Placebo Oral Capsules	7

Source ClinicalTrials.gov

Adverse events14

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	tachycardia	Cardiac disorders	Litoxetine Oral Capsules	1	53	1
other	tachycardia	Cardiac disorders	Placebo Oral Capsules	1	29	1
other	pyrexia	General disorders	Litoxetine Oral Capsules	1	53	2
other	pyrexia	General disorders	Placebo Oral Capsules	1	29	1
other	nausea	Gastrointestinal disorders	Litoxetine Oral Capsules	2	53	2
other	nausea	Gastrointestinal disorders	Placebo Oral Capsules	0	29	0
other	upper respiratory tract infection	Infections and infestations	Litoxetine Oral Capsules	2	53	2
other	upper respiratory tract infection	Infections and infestations	Placebo Oral Capsules	1	29	2
other	arthralgia	Musculoskeletal and connective tissue disorders	Litoxetine Oral Capsules	2	53	2
other	arthralgia	Musculoskeletal and connective tissue disorders	Placebo Oral Capsules	1	29	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Litoxetine Oral Capsules	0	53
Total, all-cause mortality	Placebo Oral Capsules	0	29
Total, other adverse events	Litoxetine Oral Capsules	10	53
Total, other adverse events	Placebo Oral Capsules	6	29
Total, serious adverse events	Litoxetine Oral Capsules	0	53
Total, serious adverse events	Placebo Oral Capsules	0	29

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons3

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

Comparison	Source
Litoxetine Oral Capsules vs Placebo Oral Capsules: Number of Subjects With Treatment-Emergent Adverse Events	Trial comparisons
Litoxetine Oral Capsules vs Placebo Oral Capsules: deaths from any cause	Trial comparisons
Litoxetine Oral Capsules vs Placebo Oral Capsules: 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/NCT03397771

GET https://conductscience.org/api/trials/v1/NCT03397771/registered

API reference For AI assistants