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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imipramine first | Experimental | A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2 |
|
| Placebo first | Experimental | A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Tablet | Drug | Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anal Opening Pressure (AOP) | Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR). | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonatan Kornholt, MD | Klinisk farmakologisk afdeling, Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zelo Phase I Unit, Dept. of Clinical Pharmacology, Bispebjerg Hospital | Copenhagen | Copenhagen NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39167201 | Derived | Christoffersen T, Kornholt J, Riis T, Sonne DP, Klarskov N. Effect of Single-Dose Imipramine on Anal Sphincter Tone in Healthy Women: A Randomized, Placebo-Controlled Study Using Anal Acoustic Reflectometry. Int Urogynecol J. 2024 Sep;35(9):1873-1879. doi: 10.1007/s00192-024-05890-5. Epub 2024 Aug 21. |
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Randomization determining order of arms after enrollment. At least 1 week wash out between study days. Followup 5 days after last study day to collect adverse events.
Subjects were included from 16 May 2017 to 31 May 2017 and the study days was conducted from 17 May 2017 to 16 June 2017 and the last followup call to detect adverse effects was 21 June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imipramine First | A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2 Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose |
| FG001 | Placebo First | A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2 Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imipramine First | A: Imipramine Hydrochloride 25 MG x2 B: Placebo Oral Tablet x2 Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urethral Opening Pressure (UOP) | Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR). | Posted | Mean | Standard Deviation | cmH2O | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. |
|
From study day 1 to 5 days after 2nd study day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imipramine | Imipramine Hydrochloride 25 MG x2: Two Imipramin DAK film coated tablets 25 mg each, single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach cramps | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonatan Kornholt | Department of Clinical Pharmacology, University Hospital Bispebjerg and Frederiksberg | +4538635604 | jonatan.kornholt@regionh.dk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2019 | Jul 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007099 | Imipramine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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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.
| Imipramine Hydrochloride 25 MG | Drug | Two Imipramin DAK film coated tablets 25 mg each, single dose |
|
|
| Placebo First |
A: Placebo Oral Tablet x2 B: Imipramine Hydrochloride 25 MG x2 Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Anal Opening Pressure (AOP) | Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR). | Posted | Mean | Standard Deviation | cmH2O | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Placebo | Placebo Oral Tablet x2: Two placebo film coated tablets containing lactose monohydrate, potato starch, gelatine, magnesium stearate, and talc | 0 | 16 | 0 | 16 | 1 | 16 |
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Tired | General disorders | Non-systematic Assessment |
|
| Dizzy | Nervous system disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |