Condition category
Infections and Infestations
Date applied
03/05/2011
Date assigned
19/05/2011
Last edited
16/12/2015
Prospective/Retrospective
Prospectively 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

Miss Lili Xu

ORCID ID

Contact details

207 Rui Jin Er Lu
Shanghai
200025
China
-
luckylilyxu@yahoo.com.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis: a single-centre, open-label, randomised controlled study

Acronym

Study hypothesis

Clonorchiasis is one of important food-borne trematodiases which is highly prevalent in east and southeast Asia, especially in China, Korea, northern parts of Vietnam, and the far eastern part of Russia. Chemotherapy is the mainstay for the control of food-borne trematodiasis. Currently, praziquantel is the drug of choice for clonorchiasis. According to the recommendation from World Health Organisation (WHO), the appropriate treatment schedule is 25 mg/kg thrice daily for up to 2 days which results in cure rates of 94–100% . Promotion of this dose schedule of praziquantel in mass treatment of clonorchiasis may have certain difficulty, while administration of single dose or reduction of treatment course results in less or unstable efficacy. Therefore, it still needs to develop the new drugs against C. sinensis. In recent years, we found that oral administration of single-dose tribendimidine and mebendazole and multiple-dose albendazole are efficacious. Tribendimidine exhibits not only potential effect against C. sinensis but also potential effect against juvenile C. sinensis. Albendazole was reported to be effective against C. sinensis in rats, and similar results were also shown in experimentally infected dogs. Up to 2005, an experimental study indicated that albendazole and mebendazole showed a potential effect against adult C. sinensis in rats and their single complete curative dose was 150 mg/kg. We aim to assess the efficacy and safety of tribendimidine, mebendazole and albendazole compared with that of praziquantel in patients with parasitologically confirmed Clonorchis sinensis.

Ethics approval

Ethical Review Committee of the National Institute of Parasitic Diseases, China CDC, 29/04/2011, no. 2011042901

Study design

Single-centre open-label randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Clonorchiasis

Intervention

Current interventions as of 14/08/2012:
The intervention consists of four treatments, all the medicine is administered orally to each person
1. Multiple-dose praziquantel serves as control, and the total dose is 75 mg/kg (18.75mg/kg twice daily for two days consecutively).
2. Single-dose tribendimidine 400mg.
3. Two doses, on the same day, of Tribendimidine 200mg. The total dose is 400 mg.
4. Single-dose mebendazole 400mg.
All the participants are supervised after treatments, and are asked to report any potential drug related symptoms at 3h and 24h after each time of taking medicine.

Previous interventions until 14/08/2012:
The intervention consists of four treatments, all the medicine is administered orally to each person

1. Multiple-dose praziquantel servers as control, and the total dose is 75 mg/kg(18.75mg/kg twice daily for 2 days consecutively)
2. Single-dose tribendimidine(400mg)
3. Multiple-dose mebendazole, and the total dose is 1500mg (500mg once daily for 3 days consecutively )
4. Multiple-dose albendazole, the total dose is 3200mg( 400mg twice daily for 4 consecutive days).
All the participants are supervised after treatments, and are asked to report any potential drug related symptoms at 24h, 48h, 72h, 96h, 120h and 144h after the first dose

Intervention type

Drug

Phase

Not Applicable

Drug names

Praziquantel, tribendimidine, mebendazole, albendazole

Primary outcome measures

1. Egg reduction rate (ERR) and cure rate (CR), measured using the Kato-Katz stool examination method
2. Adverse reactions, measured using a standardised questionnaire. The intensity of adverse events was graded as mild, moderate, severe and serious

Assessed at 4 weeks after treatment

Secondary outcome measures

All the participants who are to receive the tribendimidine treatment will accept checks of blood, urine, electrocardiogram, liver function and kidney function before and after the treatment. The abnormal indexes will be supervised and recorded.

Overall trial start date

25/06/2012

Overall trial end date

15/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 14/08/2012:
Eligible patients are residents of Hunan province aged 15 to 65 years who have Clonorchis sinensis infections, both sexes.

Previous inclusion criteria until 14/08/2012:
Eligible patients are residents of Guangdong province aged 2 years and above who had Clonorchis sinensis infections, both sexes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 participants

Participant exclusion criteria

1. Pregnant or lactating women
2. Presence of any abnormal medical condition, such as heart disease, high blood pressure, severe malnutrition, severe liver and kidney disease, psychiatric and neurologic disorders
3. Use of praziquantel , tribendimidine, albendazole and mebendazole or any anthelminthic treatment within the past month
4. Enrolled in any other clinical investigation during the study

Recruitment start date

25/06/2012

Recruitment end date

15/08/2012

Locations

Countries of recruitment

China

Trial participating centre

207 Rui Jin Er Lu
Shanghai
200025
China

Sponsor information

Organisation

The National Institute of Parasitic Diseases (China)

Sponsor details

China CDC
207 Rui Jin Er Lu
Shanghai
200025
China
+86 (0)21 6437 7008
luckylilyxu@yahoo.com.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute of Parasitic Diseases, China CDC (China)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25122121

Publication citations

Additional files

Editorial Notes

On 17/01/2012 the overall trial start date was changed from 15/05/2011 to 15/02/2012 and the overall trial end date was changed from 15/07/2011 to 15/05/2012. On 14/08/2012 this record was updated extensively to reflect a change in protocol: 1. The public title was changed from 'Efficacy and safety of praziquantel, tribendimidine, mebendazole and albendazole in patients infected with Clonorchis sinensis' to 'Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis' 2. The scientific title was changed from 'Efficacy and safety of praziquantel, tribendimidine, mebendazole and albendazole in patients infected with Clonorchis sinensis : a single-centre, open-label, randomised controlled study' to 'Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis : a single-centre, open-label, randomised controlled study' 3. The overall trial start date was changed from 15/02/2012 to 25/06/2012 4. The overall trial end date was changed from 15/05/2012 to 15/08/2012 5. The target number of participants was changed from 200 to 120