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Clinical Trials/PER-031-13
PER-031-13Unknown未知

A 14-DAY, OPEN-LABEL, MULTICENTER, DOSE-ESCALATING, SEQUENTIAL COHORT STUDY TO EVALUATE PHARMACODYNAMICS (URODYNAMICS) AND PHARMACOKINETICS, CLINICAL EFFICACY, TOLERABILITY AND SAFETY, FOLLOWING MULTIPLE DOSES (MG/KG/DAY) OF A DARIFENACIN LIQUID ORAL SUSPENSIONGIVEN B.I.D. IN CHILDREN, AGES 2 - 15 YEARS, WITH NEUROGENIC DETRUSOR OVERACTIVITY

Warner Chilcott,0 sites0 target enrollmentStarted: November 28, 2013Last updated:
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Conditions

Trial Snapshot

Phase
未知
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
2 to 15 (—)
Sex
All

Inclusion Criteria

  • •1. Male and female patients ages 2-15 years
  • •2. Documented detrusor overactivity (with decreased bladder compliance as their main sign of overactivity), associated with a known neurological condition such as
  • •meningomyelocele, and confirmed by urodynamics at baseline
  • •3. Using clean intermittent catheterization (CIC) on a regular basis, or, if CIC is indicated but not used on a regular basis at time of screening, able to initiate and perform CIC for the duration of the study
  • •4. Participating in a bowel program on a regular basis
  • •5. Body weight (above 5th and below 95th percentile) based on normative data
  • •6. Able to swallow the study medication in accordance to the protocol
  • •7. Patients and/or parent/guardian able to complete the bladder diary and follow the study procedures
  • •8. Patient and/or parent/guardian (according to local regulations) capable of understanding the given information and having signed Patient Informed Consent Form and/or Patient Assent Form after full discussion of the research nature of the treatment and its risks and

Exclusion Criteria

  • •1. Treatment with drugs known to significantly affect the urinary bladder function and urinary bladder outlet function 7 days prior to starting completion of the baseline diary and at any time during the study, treatment with solifenacin 21 days prior to completion of the baseline diary and at any time during the study, treatment with botulinum toxin, capsaicin or resiniferatoxin in the last 6 months prior to Visit 2 and at any time during the study
  • •2. Fecal impaction. Patients may be included, once this condition has resolved
  • •3. Clinically significant anatomic abnormalities or acquired disorders of the urinary tract
  • •4. Previous augmentation surgery of the bladder or reconstructive surgery of the bladder outlet
  • •5. Symptomatic urinary tract infection unresolved at time of urodynamic study and/or completion of bladder diary.
  • •6. Unexplained hematuria
  • •7. Diabetes insipidus
  • •8. Electro stimulation therapy or bladder training within 2 weeks prior to Visit 1 and at any
  • •time during the study
  • •9. Treatment with an unstable dose of any drug having significant anticholinergic side effects in the last 4 weeks prior to Visit 1 and at any time during the study
  • •10. Concomitant diseases, in which the use of darifenacin is contraindicated and moderate hepatic impairment
  • •See following criteria in protocol.

Investigators

Sponsor
Warner Chilcott,

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