Contact information
Type
Scientific
Primary contact
Dr V.E. Pannikar
ORCID ID
Contact details
20
Avenue Appia
Geneva -27
CH 1211
Switzerland
pannikerv@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
920335
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Leprosy
Intervention
Therapeutic efficacy of new MDT regimen containing Ofloxacin, in comparison with the standard World Health Organization (WHO)/MDT regimen among paucibacillary (PB) and multibacillary (MB) leprosy patients.
Intervention type
Drug
Phase
Not Specified
Drug names
Ofloxacin
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
08/04/2003
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients suspected of leprosy without previous treatments with MDT or ofloxacin in dermatological consultation and referred to the Leprosy Unit.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients with provincial addresses, temporary addresses and temporary works
2. Patients not residing in targeted areas for the study
Recruitment start date
08/04/2003
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Philippines
Trial participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
20
Avenue Appia
Geneva -27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list