Trial Outcomes & Findings for Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter? (NCT NCT03102645)
NCT ID: NCT03102645
Last Updated: 2021-02-12
Results Overview
Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.
Results posted on
2021-02-12
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Imipramine First
n=8 Participants
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
|
Placebo First
n=8 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Denmark
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
16 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR).
Outcome measures
| Measure |
Imipramine
n=16 Participants
Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose.
|
Placebo
n=16 Participants
Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
|
|---|---|---|
|
Urethral Opening Pressure (UOP)
|
2.90411 cmH2O
Standard Deviation 13.24729
|
-3.623431 cmH2O
Standard Deviation 8.279883
|
SECONDARY outcome
Timeframe: Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days.Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR).
Outcome measures
| Measure |
Imipramine
n=16 Participants
Imipramine Hydrochloride 25 MG: Two Imipramin DAK film coated tablets 25 mg each, single dose.
|
Placebo
n=16 Participants
Placebo Oral Tablet: Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
|
|---|---|---|
|
Anal Opening Pressure (AOP)
|
12.11873 cmH2O
Standard Deviation 15.79818
|
-2.989054 cmH2O
Standard Deviation 16.40355
|
Adverse Events
Imipramine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Imipramine
n=16 participants at risk
Imipramine Hydrochloride 25 MG x2: Two Imipramin DAK film coated tablets 25 mg each, single dose
|
Placebo
n=16 participants at risk
Placebo Oral Tablet x2: Two placebo film coated tablets containing lactose monohydrate, potato starch, gelatine, magnesium stearate, and talc
|
|---|---|---|
|
Gastrointestinal disorders
Stomach cramps
|
0.00%
0/16 • From study day 1 to 5 days after 2nd study day.
|
6.2%
1/16 • Number of events 1 • From study day 1 to 5 days after 2nd study day.
|
|
Gastrointestinal disorders
Dry mouth
|
18.8%
3/16 • Number of events 3 • From study day 1 to 5 days after 2nd study day.
|
0.00%
0/16 • From study day 1 to 5 days after 2nd study day.
|
|
General disorders
Tired
|
31.2%
5/16 • Number of events 5 • From study day 1 to 5 days after 2nd study day.
|
0.00%
0/16 • From study day 1 to 5 days after 2nd study day.
|
|
Nervous system disorders
Dizzy
|
18.8%
3/16 • Number of events 3 • From study day 1 to 5 days after 2nd study day.
|
0.00%
0/16 • From study day 1 to 5 days after 2nd study day.
|
|
Nervous system disorders
Migraine
|
6.2%
1/16 • Number of events 1 • From study day 1 to 5 days after 2nd study day.
|
0.00%
0/16 • From study day 1 to 5 days after 2nd study day.
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1 • From study day 1 to 5 days after 2nd study day.
|
0.00%
0/16 • From study day 1 to 5 days after 2nd study day.
|
Additional Information
Jonatan Kornholt
Department of Clinical Pharmacology, University Hospital Bispebjerg and Frederiksberg
Phone: +4538635604
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place