- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01630252
PGL5001 Proof of Concept Study in Inflammatory Endometriosis (JADE)
A Phase IIa Efficacy and Safety Study of PGL5001 Versus Placebo Administered for up to 5 Months With Concomitant Administration of Depot Medroxyprogesterone Acetate for the Treatment of Peritoneal and/or Ovarian Endometriosis With an Inflammatory Component.
This is a prospective, three-part (Part A1, Part A2 and Part B),Phase II study investigating the efficacy, safety, pharmacokinetics and pharmacodynamics of the JNK inhibitor PGL5001 orally administered for up to 5 months with concomitant DMPA administration for the treatment of laparoscopically diagnosed inflammatory endometriosis. The part A1 is open-label, the parts A2 and B are double-blind.
The target population will be women of reproductive age and suffering from newly diagnosed peritoneal and/or ovarian endometriosis.
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
-
Bialystok, 폴란드, 15-224
- Prywatna Klinika Połozniczo-Ginekologiczna Sp z o.o.
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- The Subject must provide written informed consent prior to initiation of any study related procedures.
- The Subject must be an adult woman of reproductive age, aged from 18 and above.
- The Subject must be a newly diagnosed patient suffering from peritoneal and/or ovarian endometriosis with at least 15% of the endometriotic lesions observed at the study diagnostic laparoscopy being red inflammatory lesions and with a proven histological diagnosis.
- The Subject must consent to the scheduling of a second laparoscopy for surgical treatment at the study end.
- The Subject must have a history of pelvic pain for at least 3 months prior to the screening visit.
Exclusion Criteria:
- The Subject is over 40 years old and has a FSH serum level during Day 2-4 of her cycle ≥ 21.5 mIU/ml.
- The Subject has a positive pregnancy test at baseline or is breast-feeding or planning a pregnancy during the course of the study.
- The Subject is known for having a cause of chronic abdominal/pelvic pain other than endometriosis (e.g. inflammatory bowel disease, fibromyalgia, interstitial cystitis).
- The Subject has a history of surgical treatment for endometriosis prior to the study diagnostic laparoscopy.
- The Subject is requiring urgent surgical excision of endometriotic lesions at the time of first diagnostic laparoscopy.
- The Subject has a history (in the past 12 months) of or a current medical treatment for endometriosis other than NSAID (e.g. GnRH agonist or antagonist, danazol, continuous oral combined oestroprogestogens).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Part A2 - Active Treatment arm
PGL5001 for 8 weeks + one DMPA injection
|
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
위약 비교기: Part A2 - Placebo Treatment arm
PGL5001 matching placebo for 8 weeks + one DMPA injection
|
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
활성 비교기: Part B - Active treatment arm
PGL5001 for 20 weeks + two DMPA injections
|
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
위약 비교기: Part B - Placebo Treatment arm
PGL5001 matching placebo for 20 weeks + two DMPA 150mg injections
|
PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
실험적: Part A1 - Active Treatment arm
PGL5001 for 8 weeks + one unique DMPA 150 mg injection
|
PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection.
Second DMPA injection between 85 to 89 days after first injection
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change from baseline to end of treatment in the number and percentage of red lesions (and/or inflammatory lesions), based on total number of red and black lesions.
기간: at week 8, week 20
|
at week 8, week 20
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Elke Bestel, MD, PregLem SA
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PGL11-021
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .