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Urinary IncontinencePhase 1/2NCT03397771

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

A Phase 1/2 study testing Litoxetine in people with Urinary Incontinence, run by Ixaltis SA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Urinary Incontinence
What is being tested?
Litoxetine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteUnited States
Study dates
3 Apr 2018to 30 May 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All subjects aged 18 to 70 will be eligible for inclusion in this study if all of the following criteria apply:
  • Willing to provide written informed consent
  • Have symptoms of urinary incontinence for at least 3 consecutive months
  • For male subjects: Undergone prostatectomy at least 6 months prior to inclusion
  • 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
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  • 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

Who cannot join

  • 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.
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  • 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
  • Diagnosis of epilepsy
  • Diagnosis of acute narrow-angle glaucoma
  • History of mania or diagnosis of bipolar disorder and/or seizures
  • Subjects with uncontrolled hypertension
  • Documented history of myocardial infarction, unstable angina, and/or has undergone coronary artery bypass surgery and/or percutaneous transluminal coronary angioplasty in the past year
  • Congestive heart failure (New York Heart Association Class III or IV heart failure; Appendix 3)
  • Any concurrent condition or any clinically significant abnormality on the Screening physical examination, laboratory tests, electrocardiogram (ECG; including ischemic heart disease), Hepatitis B or C, which, in the opinion of the Investigator, may affect the interpretation of safety or efficacy data, or which otherwise contraindicates participation in a clinical study with litoxetine:
  • Hypersensitivity to litoxetine or any of its ingredients
  • History of clinically significant drug hypersensitivity
  • Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer (not applicable to male subjects with prostate cancer in whom a prostatectomy has been performed)
  • Subjects with neuropathology that could affect the lower urinary tract or nerve supply, including but not limited to multiple sclerosis, stroke, Parkinsonism, or spinal cord injury
  • Subjects with diabetes insipidus
  • Clinically significant or unstable, endocrine, hepatic, renal, immunologic, or lung disease (ie, active chronic obstructive pulmonary disease), or malignancy other than non-melanomatous skin cancer
  • Severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73m2)
  • Severe hepatic impairment (Child-Pugh B or greater)
  • Current or recent (6 months) treatment for depression, or a current diagnosis of depression or have a state of depression or suicidality at Screening.
  • History of current or recent (6 months) suicidal ideation and behaviour (SIB), or history of any suicide attempt in the past 12 months.
  • History of an addiction to drugs or alcohol within 5 years prior to screening, or of alcohol or substance abuse within the past year, as determined by the Investigator. 26. Current use of the following medications:, any serotonergic medication, nonselective irreversible monoamineoxidase inhibitors (MAOIs), cytochrome P450 (CYP)1A2 inhibitors (such as fluvoxamine, ciprofloxacin, or enoxacin), cytochrome P450 (CYP) 2D6 inhibitors (bupropion, fluoxetine, metoclopromide, paroxetine, quinidine), pimozide and thioridazine, and any other medication that would be considered a safety risk for co-administration with litoxetine (See Section 5.7.2 Prohibited Medications)
  • 27. Participation in a clinical study within the month prior to Screening, or exposure to an investigational drug which has not washed out for at least 5 half-lives since its last administration, prior to Screening.
  • 28. In the opinion of the Investigator, is at risk of non-compliance with study procedures, or cannot read, understand, or complete study-related materials (including electronic diaries), particularly informed consent.
  • 29. Participation in any clinical study of an investigational drug that may affect urinary function within 3 months prior to Screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

Other trials in United States

About this study

Official title: A Double-Blind Randomised Placebo-Controlled Phase I/IIa Dose Titration Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine up to 30 mg vs Placebo BID in Subjects With Urinary Incontinence

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

Read the detailed description

This is a double blind randomized placebo controlled study which will explore the safety, tolerability and efficacy of oral litoxetine, a highly selective SSRI, provided by dose titration to subjects suffering from urinary incontinence

Being tested
Litoxetine, placebo
Keywords
urinary incontinence, SSRI
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LitoxetineDrug

    oral study medication provided in a dose titration manner

  • placeboDrug

    placebo medication provided in a dose titration manner

Study groups in NCT03397771
Study groupRoleWhat they receive
Litoxetine oral capsulesExperimentaloral experimental study medication litoxetine
Receives: Drug: Litoxetine
Placebo oral capsulesPlacebo comparatororal comparator
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Treatment-Emergent Adverse Events

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

    Measured: from randomisation to treatment completion, an average of 8 weeks

Secondary outcomes (1)

  1. Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence

    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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2018
  2. Study start3 Apr 2018
  3. Primary completion30 May 2019
  4. Study completion30 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03397771
Sponsor's protocol ID
IXA-CSP-002
Status last verified
May 2020
First submitted
20 Dec 2017
Last updated
11 Jun 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Litoxetine in people with Urinary Incontinence, run by Ixaltis SA at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Treatment-Emergent Adverse Events (time frame: from randomisation to treatment completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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