Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT00832078
  4. Details
NCT00832078 Clinical Trial

Test Catheter Pilot Study in Healthy Volunteers

Healthy Clinical Trial

— Test catheter  

Official title:
Test Catheter Pilot Study in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00832078
Other study ID # DK058CC
Secondary ID
Status Completed
Phase N/A
First received January 26, 2009
Last updated August 2, 2012
Start date January 2009
Est. completion date April 2009

Study information
Verified date August 2012
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- Male

- Signed informed consent

- Negative urine multistix

Exclusion Criteria:

- Abnormalities, diseases or surgical procedures performed in the lower urinary tract

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• SpeediCath Compact Male
CH 12 hydrophilic coated intermitten compact catheter
• Speedicath
CH 12 hydrophilic coated intermittent coated catheter

Locations
Country Name City State
Denmark Rigshopsitalet Copenhagen København Ø

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Discomfort Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort) After each catheterisation Yes
Secondary Handling After each catheterisation No
Secondary Preference At study termination No
Secondary Haematuria After each catheterisation Yes
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1