CTRI/2011/09/002004已完成2 期
A Phase II, Prospective, Randomized, Double blind, Within-Subject Control, Multi-Center Study to Determine the Safety and Efficacy of GRANEXIN GEL in Reducing Scar Formation in Surgical Incisional Wounds following Laparoscopic Surgery - Nil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
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 aged 18 years and older.
- •2a. Female subjects must be post-menopausal or surgically sterilized.
- •2b. Female subjects of childbearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra-uterine device or diaphragm with spermicide or condom with spermicide or abstinence throughout the study.
- •3. Subjects undergoing Laparoscopic procedures with at least two 10 mm long full-thickness surgical incisions.
- •4. Signed informed consent form.
排除标准
- •1. Subjects with a history of skin irritation or infection in the past 6 months in the intended area of incision.2. Subjects with a history of keloids.3. Known conditions of collagen vascular diseases.4. Subjects with clinically significant medical conditions as determined by the Investigator, which would impair wound healing including renal, hepatic, hematologic, neurologic or immune disease.
- •Examples include but are not limited to:
- •a. Renal insufficiency as an estimated GFR, which is 30 mL/min/1.7m2.
- •b. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.
- •c. Hepatic insufficiency defined as total bilirubin 2 mg/dL or serum albumin 25 g/L.
- •d. HbA1c 9.0%.
- •e. Hemoglobin 10 g/dL in males and 9 g/dL in females.
- •f. Hematocrit 0.30.
- •g. Platelet count 100,000.
- •5. Presence of an active systemic or local cancer or tumor of any kind (with the exception of nonmelanoma skin cancer).6. Current treatment with systemic corticosteroids (15 mg/day), or immunosuppressive agents.7. Previous or current radiation therapy or likelihood to receive this therapy during study participation.8. Pregnant or nursing subjects.9. Known prior inability or unavailability to complete required study visits during study participation.10. A psychiatric condition (e.g., suicidal ideation) or chronic alcohol or drug abuse problem, determined from the subjects medical history, which, in the opinion of the Investigator, may pose a threat to subject compliance.11. Use of any investigational drug or therapy within the 28 days prior to screening.12. Any other factor, which may, in the opinion of the Investigator, compromise participation and follow-up in this study.
研究者
相似试验
已完成
2 期
Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Diabetic Foot UlcerCTRI/2011/09/001984FirstString Research Inc92
已完成
2 期
To study the Safety and Efficacy of GRANEXIN GEL plus Standard of Care in comparison to Standard of Care alone in the Treatment of Venous Leg UlcerCTRI/2011/09/001985FirstString Research Inc92
进行中（未招募）
1 期
The effect of SJX-653 on Menopausal Hot FlashesEUCTR2019-002281-12-PLSojournix, Inc130
进行中（未招募）
1 期
The effect of SJX-653 on Menopausal Hot FlashesTreatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.MedDRA version: 21.1Level: LLTClassification code 10027311Term: Menopause flushingSystem Organ Class: 100000004872EUCTR2019-002281-12-ESSojournix, Inc
进行中（未招募）
1 期
The effect of SJX-653 on Menopausal Hot FlashesEUCTR2019-002281-12-DESojournix, Inc66