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

NCT03397771 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IXA-CSP-002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence

Keywords

urinary incontinence, SSRI

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment-Emergent Adverse Events

  AE, SAE, AE of special interest occuring after the start of treatment (LTX or PBP)

  from randomisation to treatment completion, an average of 8 weeks

Secondary Outcomes (1)

• Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence

  change in number of incontinence episodes from baseline to week 8 of treatment

Study Arms (2)

Litoxetine oral capsules

EXPERIMENTAL

oral experimental study medication litoxetine

Drug: Litoxetine

Placebo oral capsules

PLACEBO COMPARATOR

oral comparator

Drug: placebo

Interventions

Litoxetine DRUG

oral study medication provided in a dose titration manner

Litoxetine oral capsules

placebo DRUG

placebo medication provided in a dose titration manner

Placebo oral capsules

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide written informed consent
• Have symptoms of urinary incontinence for at least 3 consecutive months
• Have at least 7 incontinence episodes per week in the diary entries for the Screening Placebo Run In Period
• Subject is ambulatory and able to use the toilet independently
• If subjects use pelvic floor exercises, subjects must have been on a stable exercise and activity regime for at least 3 months prior to screening and that regime must remain stable during the treatment period
• Subject has a body mass index (BMI) ≥ 19 kg/m2 but ≤ 35 kg/m2 BMI=weight \[kg\] / height \[m2}
• Subjects must have a pre-dose mean systolic/diastolic blood pressure of ≤ 140/90 mmHg before randomization can occur
• For female subjects: Must not be pregnant, lactating, or actively trying to become pregnant, Subjects who are premenopausal and of childbearing potential must have a negative pregnancy test at Screening (serum) and at Day 0 (urine) and must use a medically acceptable and effective method of birth control for the duration of the study, which can include:
• Having a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
• Use of double-barrier methods of contraception; condoms with the use of caps (with spermicide) and intra-uterine devices are acceptable
• Use of hormonal contraceptives (oral, depots, patches, etc.) with double-barrier methods of contraception as outlined above
• True abstinence: When this is in line with the preferred and usual lifestyle of the subject (period abstinence \[eg, calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception)
• Subjects taking oral contraceptives or hormone replacement therapy (women) or hormone adjuvant therapy (men) must have a stable dose and regimen for ≥ 3 months prior to entry into the study

You may not qualify if:

• A subject will not be eligible to participate in the study if they meet any of the following criteria:
• History of anti-incontinence surgery in past 12 months
• Use of Botox for the treatment of urinary incontinence in the past 12 months
• Current or recent (3 months) use of any pharmacologic agent used to treat symptoms of urinary incontinence
• For women: Grade III/IV pelvic organ prolapse; defined per clinical practice
• For women: History of pelvic prolapse repair or urethral diverticulectomy within 12 months of Screening.
• For men: urethral surgery within 6 months of Screening
• History of interstitial cystitis or bladder-related pain
• Subjects with concurrent (at Screening), recent (within 30 days), chronic, or recurrent (\> 4 per year) urinary tract infections (positive dipstick for urinary tract infection and abnormal microscopic evaluation, signs and symptoms) or unevaluated microhematuria
• History of diagnosed gastrointestinal obstructive disorders
• Chronic severe constipation
• History of radiation cystitis or history of pelvic irradiation
• Electrostimulation, biofeedback, or bladder training therapy (behavioural therapy), during the previous month prior to Screening, or the intention to initiate such therapies during the study period. Pessaries and implants are also excluded.
• Postvoid residual (PVR) urine volume \> 150 mL
• Diagnosis of dementia

Sponsors & Collaborators

• Ixaltis SA: lead

Study Sites (1)

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

litoxetine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Development Officer
• Organization: Ixaltis

svanberg@ixaltis.com

33457260076

Study Officials

• E Svanberg

  Ixaltis SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind placebo control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 12, 2018
• Study Start: April 3, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Locations

US (1)