Condition category
Infections and Infestations
Date applied
05/04/2005
Date assigned
07/06/2005
Last edited
15/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janis Lazdins

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
-
lazdinsj@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

980819

Study information

Scientific title

To determine the safety, tolerability and systemic absorption of Diethylcarbamazine (DEC) from a "patch" applied locally to the skin for the diagnosis of Onchocerca volvulus infection (Clinical trials of drugs for onchocerciasis) (Ghana)

Acronym

Study hypothesis

The patch based on transdermal drug delivery technology is safe and well tolerated in subjects infected with Onchocerca volvulus and results in recognizable and specific skin reactions.

Ethics approval

1. Ghana Health Service Ethical Review Committee (last approval 30/03/2005)
2. World Health Organization (WHO) Ethics Review Committee (last approval date 21/11/2005)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Onchocerciasis

Intervention

Two types of Diethylcarbamazine (DEC) patches (Onchocerciasis Control Programme [OCP] and Lohmann Therapie-System [LTS]) applied to two groups each of 15 subjects. OCP applied on day one to one iliac crest after overnight fast. After a study and washout period of four days, the LTS patch applied on the other iliac crest and similar blood sampling repeated.

Intervention type

Drug

Phase

Not Applicable

Drug names

Diethylcarbamazine

Primary outcome measures

To determine the safety, tolerability and potential utility under field conditions for the diagnosis of onchocerciasis of the LTS patch 2 prototype in subjects known to be infected with Onchocerca volvulus. The utility of LTS patch 2 for field use will depend on the ease of preparation, application and readout of the results.

Secondary outcome measures

1. To compare the positive reaction rates of the OCP and LTS patches as determined at 24 and 30 hours after application
2. To determine the underlying pathology of the skin reactions from the histopathology of skin punch biopsies taken from selected subjects

Overall trial start date

12/06/2003

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males in good general health, with O. volvulus infection
2. Written, signed and dated informed consent
3. Age 18 to 55 years
4. Weight over 40 kg
5. Healthy as determined by medical history, physical exam, Electrocardiogram (ECG) and clinical lab results
6. Adequate lab functions:
6.1. White Blood Cell count (WBC) more than 3,500 and 12,000 cells/ml
6.2. Haemogloblin (Hb) more than 11.0 g/dl
6.3. Platelets count more than 110,000 mm^3
6.4. Serum creatinine less than 1.25 x Upper Limit of Normal (ULN)
6.5. Total bilirubin less than 1.25 x ULN
6.6. Aspartate Transaminase (AST)/Serum Glutamic Oxaloacetic Transaminase (SGOT) less than 1.25 x ULN
6.7. Alkaline Phosphatase (AP) more than 1.25 x ULN
7. Skin microfilarial (mf) density of 5 to 15 mg as determined at the iliac crests

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

30

Participant exclusion criteria

1. Ocular onchocerciasis
2. Hyper-reactive onchodermatitis
3. Skin lesions over iliac crests
4. Coincidental infection with Mansonella streptocera
5. Significant Electrocardiogram (ECG) abnormalities or history of cardiac abnormality
6. History of drug or alcohol abuse
7. Any other condition that the investigator feels would exclude the subject

Recruitment start date

12/06/2003

Recruitment end date

01/08/2006

Locations

Countries of recruitment

Ghana

Trial participating centre

World Health Organization
Geneva
CH-1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26452723

Publication citations

Additional files

Editorial Notes

15/04/2016: Publication reference added.