Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?

NCT03102645 | Completed Phase 1 Results

• 1 other identifier: TCA-UPR-0001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg. Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure (UOP) is measured with Urethral Pressure Reflectometry (UPR). UOP increases correlate with effect in treating stress urinary incontinence. Can imipramine treat stress urinary incontinence? Secondary objective: Does imipramine increase the tone of the anal sphincter? The opening pressure is measured with Anal Acoustic Reflectometry (AAR). The investigators also wish to establish the within-subject standard deviation for AAR to enable power calculations in future studies.

Conditions

Urinary Incontinence, Stress; Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• Urethral Opening Pressure (UOP)

  Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).

  Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.

Secondary Outcomes (1)

• Anal Opening Pressure (AOP)

  Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.

Study Arms (2)

Imipramine first

EXPERIMENTAL

A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2

Drug: Placebo Oral Tablet; Drug: Imipramine Hydrochloride 25 MG

Placebo first

EXPERIMENTAL

A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2

Drug: Placebo Oral Tablet; Drug: Imipramine Hydrochloride 25 MG

Interventions

Placebo Oral Tablet DRUG

Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc

Imipramine first; Placebo first

Imipramine Hydrochloride 25 MG DRUG

Two Imipramin DAK film coated tablets 25 mg each, single dose

Also known as: Imipramin DAK

Imipramine first; Placebo first

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed consent form.
• Healthy.
• Female.
• Non-smoker.
• Age 18 to 55, both inclusive.
• Normal weight: BMI 19.5 to 30.0 kg/m2. Weight minimum 50 kg.
• No breastfeeding.
• No pregnancy during the study.
• No other clinical trials during the study.

You may not qualify if:

• Known allergy to imipramine or any of the other known constituents.
• Medical history with significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, genitourologic, dermatologic, psychiatric, neurologic or dermatologic disease, lung disease, kidney disease, malignant disease or other significant diseases as assessed by the investigator.
• Medical history of urinary incontinence.
• Infectious disease 1 week prior to study day 1 or study day 2.
• Clinically significant findings during the physical examination.
• Pregnancy.
• Heart rate \< 40 or \> 100 beats per minute. Mean systolic blood pressure \> 140 mmHg or mean diastolic blood pressure \> 90 mmHg (mean of the measures on the screening day).
• Prescription, over the counter or herbal medication two weeks prior to study day 1 or study day 2. Excluding paracetamol and excluding oral contraceptives.
• Smoking 3 months prior to study day 1 or study day 2.
• Alcohol abuse, meaning \> 14 units (12 g alcohol) per week within three weeks prior to study day 1 or study day 2.
• Drug abuse 3 months prior to study day 1 or study day 2.
• Any condition as assessed by the investigator.

Sponsors & Collaborators

• Jonatan Kornholt: lead

Study Sites (1)

Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress; Fecal Incontinence

Interventions

Imipramine

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jonatan Kornholt
• Organization: Department of Clinical Pharmacology, University Hospital Bispebjerg and Frederiksberg

jonatan.kornholt@regionh.dk

+4538635604

Study Officials

• Jonatan Kornholt, MD

  Klinisk farmakologisk afdeling, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Packaging, randomization and masking of investigational drugs (imipramine and placebo) by Region Hovedstadens Apothecary before delivery to investigator. Sealed envelope with participant ID and drug data will be opened after data analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident doctor in the Department of Clinical Pharmacology

Model Details: 16 healthy female subjects. Double-blinded, crossover study on two days with 1 week washout. Either placebo or imipramine 50 mg single dose before and after measurement of UOP and AOP.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 6, 2017
• Study Start: May 16, 2017
• Primary Completion: June 16, 2017
• Study Completion: June 21, 2017
• Last Updated: February 12, 2021
• Results First Posted: February 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)