Research with human participants

Overview of medical research in the Netherlands

A SINGLE-BLIND, RANDOMIZED, ESCALATING MULTIPLE DOSE STUDY (PART 1) AND A SEVEN TREATMENT CROSSOVER BIOAVAILABILITY STUDY (PART 2) OF LT-NS001 AND NAPROXEN ADMINISTERED IN HEALTHY SUBJECTS

Published:
Last updated:

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Interventional

ID

NL-OMON31529

Source

ToetsingOnline

Brief title

LT-NS001 escalating multiple dose and bioavailability study

Condition

  • Other condition

Synonym

Chronic pain

Health condition

Chronische pijn zoals bij Rheumatische arthritis

Research involving

Human

Sponsors and support

Primary sponsor :
Logical Therapeutics, Inc
Source(s) of monetary or material Support :
Logical Therapeutics Inc

Intervention

Keyword :
Bioavailability, LT-NS001, Single-blind

Outcome measures

Primary outcome

-

Secondary outcome

-

Background summary

-

Study objective

-

Study design

-

Intervention

-

Study burden and risks

-

Public
Logical Therapeutics, Inc

255 Bear Hill Rd, 4th Floor
Waltham, MA 02451
USA
Scientific
Logical Therapeutics, Inc

255 Bear Hill Rd, 4th Floor
Waltham, MA 02451
USA

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Healthy subjects
Male, 18-70, inclusive (Part 1)
Male/Female, 45-70, inclusive(Part 2), famales must be post menopausal

Exclusion criteria

Pathology for example Hepatitis B, Cancer or HIV/AIDS.
If you have participated in any other drug investigation within 90 days preceding the start of this study or if you have donated blood within 60 days preceding start of this study or loss of blood of similar volume.

Design

Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Placebo
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
36
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
nvt
Generic name :
LT-NS001

Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2007-006163-71-NL
CCMO NL20480.056.07