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Status unknownNCT03490708Updated Apr 6, 2018

A Clinical Study of Tranilast in the Treatment of Mucinoses

An Early Phase 1 interventional study of Tranilast in Mucinoses, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Mucinoses

Keywords

  • Mucinoses
  • Tranilast
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinical and histopathological examination has been proved to be Mucinoses;
  2. Ultrasound and magnetic resonance detection found that the skin was thickened.

Exclusion criteria

Exclusion Criteria:

  1. With a liver or kidney disease, or accompanied by a severe infection;
  2. Poor control of primary disease;
  3. With mental disease.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Tranilast

    Subjects who were treated with tranilast

    Drug: Tranilast

Interventions

  • DrugTranilast

    Subjects will be treated with tranilast

05

What researchers measure

Primary outcomes

  1. Measure the volume change of skin lesions by ultrasound

    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

    Time frame: This experiment will last for 12 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03490708
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Apr 2018 (estimated)
Primary completion
Jun 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Apr 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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