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)
| ISRCTN | ISRCTN76875372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76875372 |
| Secondary identifying numbers | 980819 |
- Submission date
- 05/04/2005
- Registration date
- 07/06/2005
- Last edited
- 15/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Janis Lazdins
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| lazdinsj@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Diethylcarbamazine |
| Primary outcome measure | 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 study start date | 12/06/2003 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/06/2003 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- Ghana
- Switzerland
Study participating centre
World Health Organization
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/10/2015 | Yes | No |
Editorial Notes
15/04/2016: Publication reference added.
