Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/EUCTR2012-005344-15-CZ
EUCTR2012-005344-15-CZActive, not recruitingPhase 1

A Double Blind Study Aiming To Evaluate The Efficacy Of Bladder Instillation With Botulinum Toxin (200U) + TC-3 Gel In Comparison To Instillation With Botulinum Toxin (200U) + TC-3 Gel + DMSO, To DMSO Instillation and To Saline Instillation As Placebo In Overactive Bladder (OAB) Patients.

Adyton, s.r.o.0 sitesStarted: January 8, 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •At screening:
  • •1. Female subject = 18 years of age
  • •2. Signed Independent Ethical Committee (IEC) approved informed consent is obtained from the subject (prior to any study-related procedures, including withdrawal of prohibited medication, if applicable).
  • •3. Subject is willing and able to complete the micturition diary and questionnaires correctly.
  • •4. Subject has symptoms of OAB for = 3 months prior to the Screening Visit.
  • •At Randomization:
  • •1. Subject experiences at least 3 episodes of severe urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period.
  • •2. Subject experiences frequency of micturition on average = 8 times per 24-hour period during the 3-day micturition diary period.
  • •3. Subject is willing and able to complete the micturition diary and questionnaires correctly.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 35
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

  • •At Screening:
  • •1. The pregnancy test (HCG in urine) taken at screening visit is positive in women of childbearing positional.
  • •2. Female subject is breastfeeding, pregnant, intends to become pregnant during the study or of childbearing potential and sexually active and not practicing a highly reliable method of birth control.
  • •3. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
  • •4. Subject has post-void residual volume (PVR) >200 mL.
  • •5. Subject has neurogenic bladder.
  • •6. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (confirmed by a cough provocation test).
  • •7. Subject has an indwelling catheter or practices intermittent self-catheterization.
  • •8. Subject has diabetic neuropathy.
  • •9. Subject has evidence of a symptomatic urinary tract infection (urine Dipstick with nitrites present), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
  • •10. Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening).
  • •11. Subject has any other clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study.
  • •12. Subject did not respond to previous anticholinergic treatment.
  • •At Randomization:¨
  • •1. The pregnancy test (HCG in urine) taken at the Baseline Visit is positive in women of childbearing potential.
  • •2. Female subject is breastfeeding, pregnant, intends to become pregnant during the study or of childbearing potential is sexually active and not practicing a highly reliable method of birth. control.
  • •3. Subject has evidence of a symptomatic urinary tract infection (urine Dipstick with nitrites present)
  • •4. Subject has any other clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study.

Investigators

Sponsor
Adyton, s.r.o.

Similar Trials

Recruiting
Phase 4
A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.
ACTRN12619000953134RDC Global Pty Ltd610
Not yet recruiting
Phase 2
Homoeopathic Treatment of Piles.
CTRI/2024/06/068239The Calcutta Homoeopathic Medical College and Hospital
Recruiting
Phase 3
Evaluation of the effectiveness of Ipecac homeopathic remedy in control of Clinical manifestations of COVID-19covid-19.Covid-19U07.1
IRCT20140907019073N4Iran University of Medical Sciences60
Active, not recruiting
Not Applicable
Examination of effictiveness of iron containing infusion in preventing anemia after heart surgery in childre
EUCTR2014-002107-16-ATGeneral Hospital Linz
Active, not recruiting
Not Applicable
a double blind randomized study on the effectiveness of cyclopentolate 1% and cyclopentolate 1% with tropicamide 1% in dark irided hypermetropic children - effectiveness of cycloplegicsrefraction of the eye/ refractive state of the eyeMedDRA version: 9.1Level: LLTClassification code 10038264Term: Refraction disorder
EUCTR2007-003483-22-NLMedisch Centrum Haaglanden45