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

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ClinicalTrials.gov Identifier: NCT03102645
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jonatan Kornholt, Bispebjerg Hospital

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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence, Stress Fecal Incontinence Drug: Placebo Oral Tablet Drug: Imipramine Hydrochloride 25 MG Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Effect of Single Dose Imipramine on the Urethral and Anal Sphincter in Healthy Women Measured With Urethral Pressure Reflectometry (UPR) and Anal Acoustic Reflectometry (AAR)
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : June 21, 2017
Actual Study Completion Date : June 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imipramine first
A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2
Drug: Placebo Oral Tablet
Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc

Drug: Imipramine Hydrochloride 25 MG
Two Imipramin DAK film coated tablets 25 mg each, single dose
Other Name: Imipramin DAK

Experimental: Placebo first
A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
Drug: Placebo Oral Tablet
Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc

Drug: Imipramine Hydrochloride 25 MG
Two Imipramin DAK film coated tablets 25 mg each, single dose
Other Name: Imipramin DAK




Primary Outcome Measures :
  1. Urethral Opening Pressure (UOP) [ Time Frame: Immediately before drug administration (baseline) and 1 hour after drug administration on both study days. ]
    Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).


Secondary Outcome Measures :
  1. Anal Opening Pressure (AOP) [ Time Frame: Immediately before drug administration (baseline) and 1 hour after drug administration on both study days. ]
    Mean change in UOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).

  2. Within subject standard deviation for delta AOP [ Time Frame: Immediately before drug administration (baseline) and 1 hour after drug administration on both study days. ]
    Standard deviation for the change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102645


Locations
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Denmark
Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Jonatan Kornholt
Investigators
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Principal Investigator: Jonatan Kornholt, MD Klinisk farmakologisk afdeling, Bispebjerg Hospital

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Responsible Party: Jonatan Kornholt, Resident doctor in the Department of Clinical Pharmacology, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03102645     History of Changes
Other Study ID Numbers: TCA-UPR-0001
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fecal Incontinence
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs