- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03490708
A Clinical Study of Tranilast in the Treatment of Mucinoses
April 1, 2018 updated by: The First Affiliated Hospital with Nanjing Medical University
56 participants with Mucinoses will be selected to receive treatment of tranilast.
After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.
Study Overview
Detailed Description
56 participants with Mucinoses will be selected.
After the signing of the informed consent ,participants will be collected the initial lesions photos,the thickness and area of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function.
During tranilast (0.1g each time, three times a day,12 months) treatment, participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness and area.
With 3 month as a time point, participants were observed for four points.
After the experiment, the experimental data will be arranged and the data of the thickness and area change of skin lesions will be statistically processed to determine whether it is meaningful.
Study Type
Interventional
Enrollment (Anticipated)
56
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical and histopathological examination has been proved to be Mucinoses;
- Ultrasound and magnetic resonance detection found that the skin was thickened.
Exclusion Criteria:
- With a liver or kidney disease, or accompanied by a severe infection;
- Poor control of primary disease;
- With mental disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranilast
Subjects who were treated with tranilast
|
Subjects will be treated with tranilast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the volume change of skin lesions by ultrasound
Time Frame: This experiment will last for 12 months
|
During tranilast (0.1g each time, three times a day, 12 months) treatment, patients need to test lesion volume.The reduction of volume greater than 50% is judged to be effective
|
This experiment will last for 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 1, 2018
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
February 4, 2018
First Submitted That Met QC Criteria
April 1, 2018
First Posted (Actual)
April 6, 2018
Study Record Updates
Last Update Posted (Actual)
April 6, 2018
Last Update Submitted That Met QC Criteria
April 1, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Connective Tissue Diseases
- Mucinoses
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Tranilast
Other Study ID Numbers
- Mucinoses MH Hou
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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