NCT01655069: LEOPARD

A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076

Completed Phase 3 Results posted Last updated 13 November 2024

What this trial tests

Phase 3 trial testing Solifenacin succinate suspension in Urinary Bladder, Overactive in 148 participants. Completed in 8 October 2014.

Timeline

4 October 2012

Primary endpoint
8 October 2014

8 October 2014

Quick facts

Lead sponsor	Astellas Pharma Europe B.V.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	148
Start date	4 October 2012
Primary completion	8 October 2014
Estimated completion	8 October 2014
Sites	39 locations across Denmark, South Africa, Serbia and Montenegro, Ukraine, Belgium, Sweden, United Kingdom, Poland

Drugs / interventions tested

• Solifenacin succinate suspension — full drug profile →

Conditions studied

• Urinary Bladder, Overactive — all drugs for Urinary Bladder, Overactive →

Sponsor

Astellas Pharma Europe B.V. — full company profile →

Who can join

Adults 5 to 17, any sex, with Urinary Bladder, Overactive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) Primary · From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).

The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that

TEAE - Mild

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	72
Adolescents (Aged 12 to Less Than 18 Years)	10

TEAE - Moderate

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	20
Adolescents (Aged 12 to Less Than 18 Years)	8

TEAE - Severe

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1
Adolescents (Aged 12 to Less Than 18 Years)	2

Any TEAE

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	93
Adolescents (Aged 12 to Less Than 18 Years)	20

Drug-related TEAEs

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	41
Adolescents (Aged 12 to Less Than 18 Years)	11

Deaths

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	0
Adolescents (Aged 12 to Less Than 18 Years)	0

Serious TEAEs

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1
Adolescents (Aged 12 to Less Than 18 Years)	1

Drug-related serious TEAEs

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	0
Adolescents (Aged 12 to Less Than 18 Years)	0

Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Secondary · Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 w

3 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-0.92	± 0.18
Adolescents (Aged 12 to Less Than 18 Years)	-1.05	± 0.34

6 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.11	± 0.17
Adolescents (Aged 12 to Less Than 18 Years)	-1.40	± 0.33

9 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.28	± 0.19
Adolescents (Aged 12 to Less Than 18 Years)	-1.48	± 0.38

12 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.39	± 0.20
Adolescents (Aged 12 to Less Than 18 Years)	-1.66	± 0.39

24 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.61	± 0.19
Adolescents (Aged 12 to Less Than 18 Years)	-1.73	± 0.39

40 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.66	± 0.23
Adolescents (Aged 12 to Less Than 18 Years)	-1.49	± 0.36

52 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.56	± 0.22
Adolescents (Aged 12 to Less Than 18 Years)	-1.34	± 0.38

Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days Secondary · Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group

3 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1.17	± 0.16
Adolescents (Aged 12 to Less Than 18 Years)	1.69	± 0.53

6 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1.28	± 0.19
Adolescents (Aged 12 to Less Than 18 Years)	2.21	± 0.56

9 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1.59	± 0.21
Adolescents (Aged 12 to Less Than 18 Years)	1.94	± 0.50

12 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1.60	± 0.21
Adolescents (Aged 12 to Less Than 18 Years)	2.89	± 0.51

24 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	2.09	± 0.22
Adolescents (Aged 12 to Less Than 18 Years)	3.19	± 0.51

40 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	2.15	± 0.25
Adolescents (Aged 12 to Less Than 18 Years)	2.71	± 0.59

52 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	2.57	± 0.40
Adolescents (Aged 12 to Less Than 18 Years)	3.27	± 0.73

Change From Baseline in Mean Number of Micturitions Per 24 Hours Secondary · Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.

3 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-0.78	± 0.18
Adolescents (Aged 12 to Less Than 18 Years)	-1.29	± 0.39

6 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-0.96	± 0.20
Adolescents (Aged 12 to Less Than 18 Years)	-1.38	± 0.63

9 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.15	± 0.20
Adolescents (Aged 12 to Less Than 18 Years)	-1.15	± 0.61

12 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.09	± 0.21
Adolescents (Aged 12 to Less Than 18 Years)	-1.24	± 0.49

24 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.42	± 0.21
Adolescents (Aged 12 to Less Than 18 Years)	-1.01	± 0.49

40 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.43	± 0.24
Adolescents (Aged 12 to Less Than 18 Years)	-1.39	± 0.75

52 weeks solifenacin treatment

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	-1.80	± 0.43
Adolescents (Aged 12 to Less Than 18 Years)	-0.81	± 0.34

Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents Secondary · Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment

Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit.

3 weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-0.79	± 0.26

6 weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-1.36	± 0.53

9 weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-1.15	± 0.54

12 weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-1.31	± 0.38

24weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-1.11	± 0.47

40 weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-2.18	± 0.81

52 weeks solifenacin treatment

Group	Value	95% CI
Adolescents (Aged 12 to Less Than 18 Years)	-1.87	± 0.44

Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume Secondary · Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)

PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.

Group	Value	95% CI
Children (Aged 5 to Less Than 12 Years)	1.3	± 11.9
Adolescents (Aged 12 to Less Than 18 Years)	0.7	± 8.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Children (Aged 5 to Less Than 12 Years

Serious: 1/118 (1%)

Deaths: 0/118

Adolescents (Aged 12 to Less Than 18 Years)

Serious: 1/29 (3%)

Deaths: 0/29

Serious adverse events (2 terms)

Reaction	System	Children (Aged 5 to Less T…	Adolescents (Aged 12 to Le…
Gastroenteritis	Infections and infestations	—	—
Appendicitis	Infections and infestations	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Children (Aged 5 to Less T…	Adolescents (Aged 12 to Le…
Headache	Nervous system disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Electrocardiogram QT prolonged	Investigations	—	—
Pyrexia	General disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Escherichia urinary tract infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Seasonal allergy	Immune system disorders	—	—

Most-reported serious reactions: Gastroenteritis, Appendicitis.

Data from ClinicalTrials.gov NCT01655069 adverse events section.

Sponsor's own description

This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.