Back to resultsDoes Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
Primary Purpose
Urinary Incontinence, Stress, Fecal Incontinence
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Placebo Oral Tablet
Imipramine Hydrochloride 25 MG
Sponsored by
About this trial
This is an interventional basic science trial for Urinary Incontinence, Stress
Eligibility 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.
Sites / Locations
- Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Imipramine first
Placebo first
Arm Description
A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2
A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
Outcomes
Primary Outcome Measures
Urethral Opening Pressure (UOP)
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
Secondary Outcome Measures
Anal Opening Pressure (AOP)
Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03102645
Brief Title
Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
June 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonatan Kornholt
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress, Fecal Incontinence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imipramine first
Arm Type
Experimental
Arm Description
A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2
Arm Title
Placebo first
Arm Type
Experimental
Arm Description
A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
Intervention Type
Drug
Intervention Name(s)
Imipramine Hydrochloride 25 MG
Other Intervention Name(s)
Imipramin DAK
Intervention Description
Two Imipramin DAK film coated tablets 25 mg each, single dose
Primary Outcome Measure Information:
Title
Urethral Opening Pressure (UOP)
Description
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
Time Frame
Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Secondary Outcome Measure Information:
Title
Anal Opening Pressure (AOP)
Description
Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).
Time Frame
Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonatan Kornholt, MD
Organizational Affiliation
Klinisk farmakologisk afdeling, Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
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