Trial Outcomes & Findings for DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence (NCT NCT03397771)

NCT ID: NCT03397771

Last Updated: 2020-06-11

Results Overview

AE, SAE, AE of special interest occuring after the start of treatment (LTX or PBP)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 84 participants
• Primary outcome timeframe: from randomisation to treatment completion, an average of 8 weeks
• Results posted on: 2020-06-11

Participant Flow

Subjects entered the 2 week Run-in Period and received subject blind placebo treatment. Subjects who continued to meet eligibility criteria at the end of the Run-in Period (at least 7 incontinence episodes per week in the diary entries), entered the Treatment Period, randomly assigned (2:1) to receive study drug (litoxetine) for placebo BID.

Participant milestones

Measure	Litoxetine Oral Capsules oral experimental study medication litoxetine Litoxetine: oral study medication provided in a dose titration manner	Placebo Oral Capsules oral comparator placebo: placebo medication provided in a dose titration manner
Overall Study STARTED	53	29
Overall Study COMPLETED	45	22
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Measure	Litoxetine Oral Capsules oral experimental study medication litoxetine Litoxetine: oral study medication provided in a dose titration manner	Placebo Oral Capsules oral comparator placebo: placebo medication provided in a dose titration manner
Overall Study 2 erroneously randomized, never treated	3	1
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	2	2
Overall Study Adverse Event	2	1

Baseline Characteristics

DBPC Trial to Evaluate the Safety, Tolerability and Efficacy of Oral Litoxetine in Subjects With Urinary Incontinence

Baseline characteristics by cohort

Measure	Litoxetine Oral Capsules n=53 Participants oral experimental study medication litoxetine Litoxetine: oral study medication provided in a dose titration manner	Placebo Oral Capsules n=29 Participants oral comparator placebo: placebo medication provided in a dose titration manner	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	23 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	21 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	21 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: from randomisation to treatment completion, an average of 8 weeks

Population: The analysis of TEAE was conducted on the Safety Population

AE, SAE, AE of special interest occuring after the start of treatment (LTX or PBP)

Outcome measures

Measure	Litoxetine Oral Capsules n=53 Participants oral experimental study medication litoxetine Litoxetine: oral study medication provided in a dose titration manner	Placebo Oral Capsules n=29 Participants oral comparator placebo: placebo medication provided in a dose titration manner
Number of Subjects With Treatment-Emergent Adverse Events	20 Participants	10 Participants

SECONDARY outcome

Timeframe: change in number of incontinence episodes from baseline to week 8 of treatment

Population: ITT

number of incontinence episodes measured by the use of a bladder diary; change from baseline to week 8 (the higher the number the worse the incontinence severity; minimum value would be zero, there is no limit for maximum value)

Outcome measures

Measure	Litoxetine Oral Capsules n=46 Participants oral experimental study medication litoxetine Litoxetine: oral study medication provided in a dose titration manner	Placebo Oral Capsules n=22 Participants oral comparator placebo: placebo medication provided in a dose titration manner
Effect Evaluation of Litoxetine for the Treatment of Urinary Incontinence	-2.05 incontinence events Interval -2.57 to -1.54	-1.20 incontinence events Interval -1.81 to -0.58

Adverse Events

Litoxetine Oral Capsules

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo Oral Capsules

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Litoxetine Oral Capsules n=53 participants at risk oral experimental study medication litoxetine Litoxetine: oral study medication provided in a dose titration manner	Placebo Oral Capsules n=29 participants at risk oral comparator placebo: placebo medication provided in a dose titration manner
Cardiac disorders tachycardia	1.9% 1/53 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	3.4% 1/29 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.
General disorders pyrexia	1.9% 1/53 • Number of events 2 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	3.4% 1/29 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.
Gastrointestinal disorders nausea	3.8% 2/53 • Number of events 2 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	0.00% 0/29 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.
Infections and infestations upper respiratory tract infection	3.8% 2/53 • Number of events 2 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	3.4% 1/29 • Number of events 2 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.
Musculoskeletal and connective tissue disorders arthralgia	3.8% 2/53 • Number of events 2 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	3.4% 1/29 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.
Nervous system disorders somnolence	1.9% 1/53 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	3.4% 1/29 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.
Psychiatric disorders insomnia	1.9% 1/53 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.	3.4% 1/29 • Number of events 1 • TEAEs were recorded from randomization and through study completion, an average of 8 weeks The AEs reported refer to TEAEs, ie those AE which occurred after starting randomised treatment and going through week 8 of study.

Additional Information

Chief Development Officer

Ixaltis

Phone: 33457260076

Email: svanberg@ixaltis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60