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Efficacy and Safety of SYN-010 in IBS-C

November 5, 2019

Overview

Cedars-Sinai Medical Center is holding a clinical trial on the effectiveness of SYN-010 in the treatment of irritable bowel syndrome with constipation (IBS-C). Syn-010 is an oral formulation of the drug lovastatin for treating IBS-C.

 

Study Information

Researchers hypothesize reducing intestinal methane in the stomach can reverse constipation. Participants will be randomly placed in 1 of 3 study groups. One group will be given 21mg of lovastatin, another will be given 42mg of lovastatin, and the last will be given a placebo for 2 weeks.

 

Inclusion Criteria

  • All sexes, ages 18 to 65 years old
  • Willing and able to participate in the study for the required duration, understand and sign the informed consent (ICF), and be willing to comply with all protocol-related visits and procedures
  • Patient has had IBS-C symptoms for at least 6 months
  • Patient has an average of more than or equal to 3 constipated bowel movements (CSBMs) per week or more than or equal to 5 spontaneous bowel movements (SBMs) per week during the 17 days before study
  • Patient has a breath methane level more than or equal to 10 ppm on a lactulose breath test given at the beginning of study
  • Patient must agree to refrain from starting a new diet, changing stable dose of supplemental fiber, or changing exercise pattern that may affect IBS-C symptoms
  • Agree to use an acceptable method of contraception from the time of signing the ICF to 30 days after the final dose of study drug
  • Non-pregnant and non-lactating females
  • Must be able to understand and be willing to sign the written informed consent form
  • Willing and able to comply with the protocol, including follow-up visits and examinations

 

Exclusion Criteria

  • Patient has loose (mushy) or watery stools for more than 25% of their bowel movements (BMs) during the 12 weeks before study
  • History of cathartic colon, laxative, or enema abuse
  • History of ischemic colitis
  • History of pelvic floor dysfunction
  • History of bariatric surgery for the treatment of obesity
  • Has a history of surgery to remove a segment of the gastrointestinal (GI) tract
  • History of myopathy, rhabdomyolysis, chronic myalgia, or familial history of hereditary muscular disorders
  • Diagnosed with or has a family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer
  • Currently has any structural abnormality of the GI tract or a disease or condition that can affect GI motility, such as lower GI bleeding, rectal bleeding, heme-positive stool, iron-deficiency anemia, weight loss, or systemic signs of infection
  • Any previous surgery involving the abdomen, pelvis, or retroperitoneal region during the last 12 months before study
  • History of diverticulitis or any chronic condition that could be associated with abdominal pain or discomfort (e.g. inflammatory bowel disease, chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis, or lactose intolerance)
  • History of severe renal insufficiency
  • History of a medical condition or a concomitant medical condition that would compromise the patient’s ability to complete the study safely
  • Patient is known to have elevated liver enzyme levels or creatine kinase levels
  • Patient has any abnormal laboratory results, electrocardiogram (ECG) findings, or physical examination findings deemed clinically significant by the investigator of the study
  • Within 14 days before study, patient has used concomitant medications including:
    • Cyclosporine
    • Verapamil
    • Dronedarone
    • Diltiazem
    • Amiodarone
    • Itraconazole
    • Ketoconazole
    • Posaconazole
    • voriconazole
    • Clarithromycin
    • Telithromycin
    • human immunodeficiency virus protease inhibitors
    • Boceprevir
    • Telaprevir
    • Nefazodone
    • Erythromycin
    • cobicistat-containing products
    • Rifampin
    • Colchicine
    • Ranolazine
    • Metformin
    • GLP-1 agonists
  • Patient has hypersensitivity to statins; or has used any statins, fibrates over 1 gram a Current chronic or frequent use of drugs known to cause constipation (e.g. narcotics) for the 3 months before study
  • Patient has taken over-the-counter IBS treatments (e.g. laxatives) or proton pump inhibitors within 3 days prior before study
  • Certain drugs used for the treatment of IBS (e.g. low dose tricyclic antidepressants) may be allowed with the exception of tegaserod, lubiprostone, linaclotide, metoclopramide, prucalopride, domperidone, CandiBactin, Atrantil, Allimax/Allimed, or antibiotics within 2 months before study
  • Patient has used an opioid chronically or frequently within the 3 months before or during study
  • Currently enrolled in, or plans to enroll in, another clinical study or has used any investigational drug or device within 1 month before signing the ICF until study completion
  • Patient has previously participated in a SYN-010 study
  • Patient has a history of alcohol or drug abuse within the 12 months before study

 

Locations

You may participate in this study at Cedars-Sinai Medical Center in Los Angeles, California 90048. If you have any questions feel free to contact Christine Chang at 310-423-7068 or at christine.chang@cshs.org

 

Sponsors/Collaborators

This study is sponsored by Cedars-Sinai Medical Center and Synthetic Biologics Inc. The Principal Investigator is Ali Rezaie, MD MSc.

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