NCT03397771

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

Completed Phase 1, PHASE2 Results posted Last updated 11 June 2020

What this trial tests

Phase 1, PHASE2 trial testing Litoxetine in Urinary Incontinence in 84 participants. Completed in 30 May 2019.

Timeline

3 April 2018

Primary endpoint
30 May 2019

30 May 2019

Quick facts

Lead sponsor	Ixaltis SA
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	84
Start date	3 April 2018
Primary completion	30 May 2019
Estimated completion	30 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Litoxetine — full drug profile →
• placebo

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →

Sponsor

Ixaltis SA

Who can join

Adults 18 to 70, any sex, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Treatment-Emergent Adverse Events Primary · 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)

Group	Value	95% CI
Litoxetine Oral Capsules	20
Placebo Oral Capsules	10

Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence Secondary · 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)

Group	Value	95% CI
Litoxetine Oral Capsules	-2.05	-2.57 – -1.54
Placebo Oral Capsules	-1.20	-1.81 – -0.58

Adverse events — posted to ClinicalTrials.gov

Time frame: TEAEs were recorded from randomization and through study completion, an average of 8 weeks. Reporting threshold: 1.2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Litoxetine Oral Capsules

Serious: 0/53 (0%)

Deaths: 0/53

Placebo Oral Capsules

Serious: 0/29 (0%)

Deaths: 0/29

Other adverse events (7 terms — click to expand)

Reaction	System	Litoxetine Oral Capsules	Placebo Oral Capsules
nausea	Gastrointestinal disorders	—	—
upper respiratory tract infection	Infections and infestations	—	—
arthralgia	Musculoskeletal and connective tissue disorders	—	—
tachycardia	Cardiac disorders	—	—
pyrexia	General disorders	—	—
somnolence	Nervous system disorders	—	—
insomnia	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT03397771 adverse events section.

Sponsor's own description

This study will explore the safety, tolerability and efficacy of litoxetine in men and women who suffer from urinary incontinence

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.