| CTRI Number |
CTRI/2012/12/003252 [Registered on: 21/12/2012] Trial Registered Prospectively |
| Last Modified On: |
11/11/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Patients 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
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Scientific Title of Study
|
A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of
Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2011-000330-11 |
EudraCT |
| 905-CL-047 dated 22 March 2012 |
Protocol Number |
| NCT01565694 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director-Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited,
Vatika City Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
arun.sundriyal@ppdi.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Arun Sundriyal |
| Designation |
Associate Director-Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited,
Vatika City Point, 11th Floor, Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
arun.sundriyal@ppdi.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden,The Netherlands |
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Primary Sponsor
Modification(s)
|
| Name |
Astellas Pharma Europe BV |
| Address |
Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden,The Netherlands |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceutical Development India Pvt Ltd |
01-Dynasty B-Wing (Kanakia Spaces),Andheri-
Kurla Road, Andheri East, Mumbai-400059.
India |
|
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Countries of Recruitment
|
Belgium
Brazil
Canada
Denmark
India
Mexico
Netherlands
Poland
Republic of Korea
Russian Federation
Turkey
United Kingdom
United States of America
France
Germany |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailesh Anantray Shah |
Bodyline Hospitals |
Nava Vikas Gruh Road, Opp Annapurna Hall, Nr. Dev Status, Paldi – 380007
Ahmadabad
GUJARAT |
919824035673
shaileshshahuro@yahoo.com |
| Dr Rajeev Sood |
Dr. Ram Manohar Lohia Hospital & PGIMER |
Room no. 31, OPD Block, Baba Kharag Singh Marg-110001
New Delhi
DELHI |
919810005182
drsoodr@yahoo.com |
| Dr Shobha Lal Sukhdarshan |
Himalayan Institute of Medical Sciences |
Department of Urology,HIHT University, Swami Ram Nagar, P.O.-Doiwala-248140
Dehradun
UTTARANCHAL |
919837263544
lalshobha@gmail.com |
| Dr Shimpi Rajendra Kashinath |
Inamdar Multispeciality Hospital |
Hospital Building S. No. 15, Department of Surgery, Fatima Nagar, Near KPCT Mall- 411040
Pune
MAHARASHTRA |
919822059799
912030502275
rajendrakshimpi@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee-Inamdar Multispeciality Hospital (PI-Dr Rajendra Shimpi) |
Approved |
| Institutional Ethics Committee-Dr. Ram Manohar Lohia Hospital & PGIMER (PI- Dr Rajeev Sood) |
Submittted/Under Review |
| Institutional Ethics Committee-HIHT university (PI- Dr Shobha Lal) |
Approved |
| Spandan Independent Ethics Committee-Bodyline Hospital (PI- Dr Shailesh Shah) |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neurogenic Detrusor Overactivity , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open Label Trial-NA |
Open Label Trial-NA |
| Intervention |
Solifenacin succinate Oral suspension 1 mg per mL (100 mL) |
Doses will be calculated according to weight, in ranges, targeting equivalent exposure to the 2.5, 5, 7.5 and 10 mg doses once daily in adults at steady state.
Oral administration (via syringes) in the morning, with a glass of water afterwards.
Duration of treatment-52 weeks
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|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Documented diagnosis of NDO, confirmed by urodynamics.
Practicing clean intermittent catheterization (CIC).
Currently on treatment with an antimuscarinic drug.
|
|
| ExclusionCriteria |
| Details |
Known genitourinary condition (other than NDO) that may cause incontinence.
Bladder augmentation surgery.
Current Faecal impaction.
Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study.
Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention.
Reflux grade 3 or 4.
Current urinary tract infection (UTI).
Subject has severe renal impairment (glomerular filtration rate less than 30 ml/min).
Subject has severe hepatic impairment (Child-Pugh score greater than 9).
Subject has received intra-vesical botulinum toxin within 9 months prior to screening.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in maximum cystometric capacity (MCC) |
Baseline and Week 24 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Maximum Cystometric Capacity (MCC) |
Baseline, Week 9, Week 24 and Week 52 |
Change in Urodynamics
Measured by:
Bladder compliance (Change in V per Change in Pdet).
Bladder volume until first detrusor contraction (greater than 15 cmH2O).
Bladder volume at 30 cm H2O detrusor pressure.
Bladder volume at 40 cm H2O detrusor pressure.
Number of uninhibited detrusor contractions (greater than 15 cmH2O) until leakage or maximum 135 percentage of age-related bladder capacity. Detrusor pressure at leakage or 135 percentage of age-related cystometric capacity.
|
Week 9, Week 24 and Week 52 |
Change in Diary Observations
Measured by:
Average catheterized volume per catheterization.
Maximum catheterized volume per day.
Mean number of incontinence episodes per 24 hours.
Number of dry (incontinence-free) days per 7 days.
|
Baseline, Week 3 to Week 52 |
| Change in Quality of Life |
Baseline, Week 24 and Week 52 |
|
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Target Sample Size
|
Total Sample Size="74"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/10/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/08/2012 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NA |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
The purpose of this study is to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents. NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension will be investigated. The take-up and length of time that the solifenacin suspension stays in the body will also be investigated during this study.
The study will last for approximately 12 months, where completing patients will receive 52 weeks of continuous treatment.
Effectiveness will be measured by urodynamics (the filling and emptying of the bladder) and urine volumes measured during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.
Safety assessments include analysis of the blood and urine, review of the ECG, ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
Study has been discontinued in India.
No Subjects were screened or enrolled for the study in India. |