Efficacy and Safety of SYN-010 in IBS-C

Condition: Irritable bowel syndrome, constipation

Eligibility

Key Inclusion Criteria

  • 18-65 years old
  • IBS-C symptoms for at least 6 months before diagnosis
  • Average score of ≥3.0 for daily abdominal pain at its worst (11-point numerical rating scale) during and up to 17 days before assignment to treatment group

Key Exclusion Criteria

  • Loose or watery stools for >25% of their bowel movements during the 12 weeks before screening
  • History of cathartic colon, laxative, or enema abuse
  • History of ischemic colitis

Full Study Name

Evaluation of the Efficacy and Safety of Single, Daily Oral Doses of SYN-010 Compared to Placebo in Adult Patients With Irritable Bowel Syndrome With Constipation (IRB no. 54792)   

Summary

The purpose of this study is to evaluate whether an experimental drug called SYN-010 is effective in patients who have irritable bowel syndrome with constipation (IBS-C). The study aims to determine whether SYN-010 works better than placebo (inactive substance) to improve symptoms of IBS-C.  

SYN-010 is a modified-release, oral formulation of a drug called lovastatin. Lovastatin, in its unmodified form, is approved by the U.S. Food and Drug Administration (FDA) for other conditions, but it is not approved by the FDA for the treatment of IBS-C. Researchers will examine the effects of two different doses of SYN-010 on clinical symptoms of IBS-C compared with placebo. Participants will be randomly assigned to one of three treatment groups: Group 1 will receive the lower dose of SYN-010; Group 2 will receive the higher dose of SYN-010; and Group 3 will receive the placebo.

Financial disclosure

  • Cedars-Sinai owns the patent application related to the drug being tested in this study and has licensed the patent to the study sponsor.
  • Cedars-Sinai may receive royalties or other payments from the sponsor under the license agreement for the patent related to the drug being tested in this study.
  • Cedars-Sinai has equity interests with the sponsor.

Principal Investigator

Ali Rezaie, MD

Contact
Medically Associated Science and Technology (MAST) Program Office
Phone: 310-423-0617
E-mail: groupmedicinemastclinical@cshs.org