CTRI/2022/10/046658招募中2 期
A Phase II, Multicenter, Randomized, Double-blind, Placebo controlled Clinical study toevaluate efficacy and safety of PNB-001 as an adjunct to Mesalamine compared toMesalamine alone in Subjects with Inflammatory bowel disease
PNB Vesper Life Science Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female Subjects aged between 18 and 65 years (both Inclusive).
- •2.Subjects who are able to understand and willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
- •3.Subjects on stable dose of oral Mesalamine of at least 2.4 gm/day for 2 weeks prior to screening.
- •Inclusion Criteria specific for Ulcerative Colitis Participants (Cohort 1)
- •1.Subjects have a documented history of idiopathic ulcerative colitis based on standard endoscopic (colonoscopic) and histological criteria involving the whole/part of left side of the colon [approximately 60 cm up from the anus (anal verge) to splenic flexure of colon], with mild to moderate active disease].
- •2.Subjects with Ulcerative Colitis Disease Activity Index (UCDAI) score of 4-10.
- •3.Rectal bleeding score of 1 or more at baseline
- •4.Mucosal appearance score (based on endoscopy) of 1 point or more at baseline
- •5.Stool Frequency subscore of 1 or more at baseline.
- •Inclusion Criteria specific for Crohn’s Disease Participants(Cohort 2)
- •1.Subjects have a documented history of Crohns Disease(CD) established at least 3 months prior to randomization by clinical and endoscopic evidence and corraborated by a histopathology report
- •2.Has mild to moderately active CD as determined by Crohns Disease Activity Index (CDAI) score of CDAI =200 and =400
- •3.Average of greater than two liquid or soft stools per day and an abdominal pain intensity score >1
排除标准
- •1. Documented history of proximal or universal ulcerative colitis (pan colitis).
- •2. Subjects who demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
- •3. Bowel resection within the previous 6 months.
- •4. Subjects with hemoglobin of = 10 g/dl at screening.
- •5. Subjects with ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •6. Prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
- •7. Subjects with the following clinically significant laboratory abnormalities: SGOT, SGPT,
- •Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit.
- •8. Subjectswith abnormal Sr.Creatinine value of = 2 mg/dl at screening visit.
- •9. Subjects with current or recurrent Clostridium difficile infection.
- •10. History of biological therapy with agents like infliximab, adalimumab, etanercept, etc. within the previous 8 weeks of screening and Subjects in need of such therapy during the study period.
- •11. Subjects who received systemic steroids or immunosuppressant’s within the previous 4 weeks
- •of screening.
- •12. Subjects not able to withdraw and in need of continuing other immunosuppressant’s like sirolimus or cyclosporine during the study period.
- •13. Subjects with alcohol or drug abuse
- •14. Subjects with history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-
- •HCV) positive, or other clinically active liver disease at screening.
- •15. Subjects with Type 1 Diabetes or Type 2 Diabetes Mellitus whose diabetes has not been stable
- •and uncontrolled for the previous three months and with HbA1c value greater than 8% at
- •16. Subjects with cerebrovascular disease in the previous 3 months
- •17. Subjects diagnosed or suffering from any Oncological Conditions since last 2 years will be
- •excluded from the study.
- •18. Subjects with pre-existent renal function disorders, liver function disorders, cardiac disease,
- •uncontrolled hypertension, clinically important hematological, metabolic, psychiatric, central
- •nervous system (CNS) or pulmonary disease.
- •19. Female subjects who are pregnant or lactating or planning to become pregnant during the study
- •period. Females who are not ready to use acceptable contraceptive methods during the course
- •20. Subjects who participated in any other clinical or post-marketing study (not only for study
- •drugs but also for medical devices) 30 days before signing the informed consent
- •21. Any condition which the study physician judges to preclude safe participation in the study or to
- •confound the evaluation of the study outcome.
研究者
相似试验
未知
2 期
A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple SclerosisMultiple SclerosisJPRN-jRCT2080222132ovartis Pharma K.K.380
未知
2 期
Phase II study of TAS-102 in patients with metastatic colorectal cancerJPRN-jRCT2080220849Taiho Pharmaceutical Co., Ltd.162
招募中
2 期
AMG0103 in Subjects with Chronic Discogenic Lumber Back PaiChronic Discogenic Lumber Back PainJPRN-jRCT2031230145Sakai Daisuke92
进行中（未招募）
不适用
Ganitumab in Locally Advanced Unresectable Adenocarcinma of the Pancreasocally advanced adenocarcinoma of the pancreasMedDRA version: 14.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023978-39-GBAmgen Inc150
进行中（未招募）
不适用
Ganitumab in Locally Advanced Unresectable Adenocarcinma of the Pancreasocally advanced adenocarcinoma of the pancreasMedDRA version: 14.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023978-39-DEAmgen Inc150