Efficacy and Dose Ranging Study of Seroguard

Summary

This trial was a multi-center, double-blind, randomized, parallel group, placebo-controlled, phase II study in adult hospitalized female patients with the confirmed diagnosis of pelvic adhesive disease in Study centres in Russia.

Timeline

Start

2017-05-04

Primary completion

2018-01-23

Completion

2018-01-23

Publications

• Background Miller JH, Weinberg RK, Canino NL, Klein NA, Soules MR. The pattern of infertility diagnoses in women of advanced reproductive age. Am J Obstet Gynecol. 1999 Oct;181(4):952-7. doi: 10.1016/s0002-9378(99)70331-5.
• Background Dun EC, Nezhat CH. Tubal factor infertility: diagnosis and management in the era of assisted reproductive technology. Obstet Gynecol Clin North Am. 2012 Dec;39(4):551-66. doi: 10.1016/j.ogc.2012.09.006.
• Background Westrom L. Effect of acute pelvic inflammatory disease on fertility. Am J Obstet Gynecol. 1975 Mar 1;121(5):707-13. doi: 10.1016/0002-9378(75)90477-9.
• Background Westrom LV. Sexually transmitted diseases and infertility. Sex Transm Dis. 1994 Mar-Apr;21(2 Suppl):S32-7.
• Background Patil M. Assessing tubal damage. J Hum Reprod Sci. 2009 Jan;2(1):2-11. doi: 10.4103/0974-1208.51335.
• Background Sutherland AM. The changing pattern of tuberculosis of the female genital tract. A thirty year survey. Arch Gynecol. 1983;234(2):95-101. doi: 10.1007/BF00207681.
• Background Mueller BA, Daling JR, Moore DE, Weiss NS, Spadoni LR, Stadel BV, Soules MR. Appendectomy and the risk of tubal infertility. N Engl J Med. 1986 Dec 11;315(24):1506-8. doi: 10.1056/NEJM198612113152402.
• Background Schwartz L, Diamond M. Formation, Reduction, and Treatment of Adhesive Disease. Seminars in Reproductive Medicine. 1991; 9(02): p. 89-99.
• Background Vaid K, Mehra S, Verma M, Jain S, Sharma A, Bhaskaran S. Pan endoscopic approach "hysterolaparoscopy" as an initial procedure in selected infertile women. J Clin Diagn Res. 2014 Feb;8(2):95-8. doi: 10.7860/JCDR/2014/7271.4018. Epub 2014 Feb 3.
• Background Neerja, Jain K. Role of laporoscopy-hysteroscopy in cases of infertility with pregnancy outcome. J Indian Med Assoc. 2014 Feb;112(2):85-6, 88.
• Background Diamond MP, Daniell JF, Feste J, Surrey MW, McLaughlin DS, Friedman S, Vaughn WK, Martin DC. Adhesion reformation and de novo adhesion formation after reproductive pelvic surgery. Fertil Steril. 1987 May;47(5):864-6. doi: 10.1016/s0015-0282(16)59181-x.
• Background DeCherney AH, Mezer HC. The nature of posttuboplasty pelvic adhesions as determined by early and late laparoscopy. Fertil Steril. 1984 Apr;41(4):643-6. doi: 10.1016/s0015-0282(16)47793-9.
• Background Al-Jabri S, Tulandi T. Management and prevention of pelvic adhesions. Semin Reprod Med. 2011 Mar;29(2):130-7. doi: 10.1055/s-0031-1272475. Epub 2011 Mar 24.
• Background Brochhausen C, Schmitt VH, Planck CN, Rajab TK, Hollemann D, Tapprich C, Kramer B, Wallwiener C, Hierlemann H, Zehbe R, Planck H, Kirkpatrick CJ. Current strategies and future perspectives for intraperitoneal adhesion prevention. J Gastrointest Surg. 2012 Jun;16(6):1256-74. doi: 10.1007/s11605-011-1819-9.
• Background Coulthard LR, White DE, Jones DL, McDermott MF, Burchill SA. p38(MAPK): stress responses from molecular mechanisms to therapeutics. Trends Mol Med. 2009 Aug;15(8):369-79. doi: 10.1016/j.molmed.2009.06.005. Epub 2009 Aug 6.
• Background Ward BC, Kavalukas S, Brugnano J, Barbul A, Panitch A. Peptide inhibitors of MK2 show promise for inhibition of abdominal adhesions. J Surg Res. 2011 Jul;169(1):e27-36. doi: 10.1016/j.jss.2011.01.043. Epub 2011 Feb 23.
• Background Katada J, Saito H, Ohashi A. Significance of cyclooxygenase-2 induced via p38 mitogen-activated protein kinase in mechanical stimulus-induced peritoneal adhesion in mice. J Pharmacol Exp Ther. 2005 Apr;313(1):286-92. doi: 10.1124/jpet.104.078717. Epub 2004 Dec 2.
• Background U.S. Food and Drug Administration. U.S. Food and Drug Administration. [Online]. Northborough; 2006 [cited 2015 Dec 22. Available from: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4217b1_01_Executive%20Summary.pdf.
• Background Ghonge NP, Ghonge SD. Computed tomography and magnetic resonance imaging in the evaluation of pelvic peritoneal adhesions: What radiologists need to know? Indian J Radiol Imaging. 2014 Apr;24(2):149-55. doi: 10.4103/0971-3026.134400.
• Background diZerega GS. The peritoneum and its response to surgical injury. Prog Clin Biol Res. 1990;358:1-11. No abstract available.
• Background diZerega GS, Campeau JD. Peritoneal repair and post-surgical adhesion formation. Hum Reprod Update. 2001 Nov-Dec;7(6):547-55. doi: 10.1093/humupd/7.6.547.
• Background Lali FV, Hunt AE, Turner SJ, Foxwell BM. The pyridinyl imidazole inhibitor SB203580 blocks phosphoinositide-dependent protein kinase activity, protein kinase B phosphorylation, and retinoblastoma hyperphosphorylation in interleukin-2-stimulated T cells independently of p38 mitogen-activated protein kinase. J Biol Chem. 2000 Mar 10;275(10):7395-402. doi: 10.1074/jbc.275.10.7395.
• Background Kumar B, Koul S, Petersen J, Khandrika L, Hwa JS, Meacham RB, Wilson S, Koul HK. p38 mitogen-activated protein kinase-driven MAPKAPK2 regulates invasion of bladder cancer by modulation of MMP-2 and MMP-9 activity. Cancer Res. 2010 Jan 15;70(2):832-41. doi: 10.1158/0008-5472.CAN-09-2918. Epub 2010 Jan 12.
• Background Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG, Bramis JP. Postoperative pain relief after laparoscopic cholecystectomy: a placebo-controlled double-blind randomized trial of preincisional infiltration and intraperitoneal instillation of levobupivacaine 0.25%. Surg Endosc. 2005 Nov;19(11):1503-6. doi: 10.1007/s00464-005-3002-4. Epub 2005 Oct 3.
• Background Innes A, Burden RP, Finch RG, Morgan AG. Treatment of resistant peritonitis in continuous ambulatory peritoneal dialysis with intraperitoneal urokinase: a double-blind clinical trial. Nephrol Dial Transplant. 1994;9(7):797-9.
• Background Szem JW, Hydo L, Barie PS. A double-blinded evaluation of intraperitoneal bupivacaine vs saline for the reduction of postoperative pain and nausea after laparoscopic cholecystectomy. Surg Endosc. 1996 Jan;10(1):44-8. doi: 10.1007/s004649910011.
• Background Labaille T, Mazoit JX, Paqueron X, Franco D, Benhamou D. The clinical efficacy and pharmacokinetics of intraperitoneal ropivacaine for laparoscopic cholecystectomy. Anesth Analg. 2002 Jan;94(1):100-5, table of contents. doi: 10.1097/00000539-200201000-00019.
• Background Ahmad G, Mackie FL, Iles DA, O'Flynn H, Dias S, Metwally M, Watson A. Fluid and pharmacological agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2014 Jul 9;(7):CD001298. doi: 10.1002/14651858.CD001298.pub4.
• Background U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Non-Inferiority Clinical Trials.; 2010 [cited 2015 Dec. Available from: http://www.fda.gov/downloads/Drugs/./Guidances/UCM202140.pdf.
• Background Chow S, Shao J, Wang H. Sample Size Calculations in Clinical Research. 2nd ed.: Chapman&Hall / CRC Biostatistics Series; 2008.
• Background Guerriero S, Ajossa S, Lai MP, Mais V, Paoletti AM, Melis GB. Transvaginal ultrasonography in the diagnosis of pelvic adhesions. Hum Reprod. 1997 Dec;12(12):2649-53. doi: 10.1093/humrep/12.12.2649.
• Background Guerriero S, Ajossa S, Garau N, Alcazar JL, Mais V, Melis GB. Diagnosis of pelvic adhesions in patients with endometrioma: the role of transvaginal ultrasonography. Fertil Steril. 2010 Jul;94(2):742-6. doi: 10.1016/j.fertnstert.2009.03.035. Epub 2009 Apr 14.
• Background Julious SA. Sample Sizes for Clinical Trials: CRC Press/Taylor & Francis; 2010.
• Background Gnoth C, Godehardt E, Frank-Herrmann P, Friol K, Tigges J, Freundl G. Definition and prevalence of subfertility and infertility. Hum Reprod. 2005 May;20(5):1144-7. doi: 10.1093/humrep/deh870. Epub 2005 Mar 31.
• Background Gnoth C, Godehardt D, Godehardt E, Frank-Herrmann P, Freundl G. Time to pregnancy: results of the German prospective study and impact on the management of infertility. Hum Reprod. 2003 Sep;18(9):1959-66. doi: 10.1093/humrep/deg366.

Drugs

Indications

No indication recorded.