Trial | NCT01826045  Report issue

Title

Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
A Multi-center, Randomized, Double Blind, Placebo Control, Parallel Design, Phase 2a Trial to Evaluate the Efficacy and Safety of PGA (Poly-gamma Glutamic Acid) for the Fertile Women With Cervical Intraepithelial Neoplasia 1 (CIN1)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    l-glutamic acid ...

  • Study Participants

    200
The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).
This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1) between the treatment group and the control group.

The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks followed by 8 weeks observation.

The control group will be observed for 12 weeks without any comparator.
Study Started
Jun 30
2013
Primary Completion
Dec 31
2015
Study Completion
Jan 31
2016
Last Update
Jan 29
2016
Estimate

Drug Poly-gamma Glutamic Acid

Drug Placebo

Poly-gamma Glutamic Acid Experimental

Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered Poly-gamma Glutamic Acid for 4 weeks.

Placebo Placebo Comparator

Patients with cervical intraepithelial neoplasia 1(CIN1) will be administered placebo for 4 weeks.

Criteria 

Inclusion Criteria:

Fertile women between age of 20 and 49
Patients with cervical intraepithelial neoplasia 1(CIN1)
HPV(Human Papilloma Virus) positive(+)
White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 10^6/L
AST(Aspartate Aminotransferase) no less than 4 times higher than normal ALT(Alanine Aminotransferase) no less than 4 times higher than normal
Normal for EKG(Electrocardiography) and no active disease detected trough chest X-ray
Be informed of the nature of the study and will give written informed consent

Exclusion Criteria:

Malignant tumor in any organ other than cervical intraepithelial neoplasia
Active liver disease, immune disorder and severe renal failure
Leukemia, collagenosis, sclerosis, autoimmune disease, clinically significant allergic disease(mild allergic symptom not required medicine excluded)
Diagnosed diabetes
Taking any of followings affecting immunological reaction within 7 days (Glucocorticoid, vitamins, health food and oriental medicine etc)
Pregnancy and breastfeeding
Registered in other clinical trials
Patients whom the investigator considers inappropriate to participate in the study
No Results Posted