Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis

Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Age Range:18 - 70
Start Date:September 2014
Contact:Ankita Dubey, B.Sc
Phone:650 721 2665

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An Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild-to-Moderate Ulcerative Colitis

This is a 12-week, open-label, dose-escalation Phase 1b study of a herbal treatment given
orally to subjects with ulcerative colitis. Subjects will be sequentially enrolled to one of
two cohorts in up to two clinical sites. Treatment will be given for 8 weeks and study
duration will be 12 weeks.

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 70 years.

2. Mild-to-moderate ulcerative colitis beyond the rectum

3. Mayo Scoring System Assessment of Ulcerative Colitis Activity score of 4 to 10 at
screening with mayo rectal bleeding subscore of at least 1 at screening; Physician's
Global Assessment (PGA) Mayo subscore of at least 1 at screening.

4. Patients with active disease who are refractory or intolerant to 5-aminosalicylic
acid (5-ASA).

5. Endoscopic evidence of active mucosal disease as assessed by colonoscopy with Mayo
mucosal appearance subscore of at least 1 at screening.

6. Female patients of child-bearing potential must have a negative serum pregnancy test
at the screening visit and agree to use two medically reliable methods of
contraception (such as barrier with either spermicide or hormonal contraception)
during the study period.

7. Male patients must be willing to use acceptable contraceptive methods and assure that
their female partners of child-bearing potential use acceptable contraceptive methods
during the study period.

8. Ability to adhere to the study visit schedule and other protocol requirements.

9. Adequate cardiac, renal, and hepatic function as determined by the principal

10. Written informed consent will be obtained before any study procedure is performed.

Exclusion Criteria:

1. Are nursing or pregnant.

2. Ulcerative colitis that is limited to the rectum

3. Ulcerative colitis that requires surgical, endoscopic, or radiologic intervention.

4. Patients who are hospitalized or exhibiting signs of toxicity (abdominal distension,
severe abdominal tenderness, fever, nausea).

5. Crohn's disease or indeterminate colitis.

6. Known sensitivity to any ingredients in the study drug.

7. Use of 5-ASA at any time within 1 week prior to baseline visit.

8. Use of corticosteroids within 4 weeks before the baseline visit.

9. Use of immunomodulators (cyclosporine, mercaptopurine, azathioprine, etc.) at any
time within 12 weeks before the baseline visit.

10. Use of biologics within 12 weeks before the baseline visit.

11. If on probiotics, must be on a stable dose for at least 4 weeks prior to baseline

12. Use of any dietary supplements concomitantly with the study drug that the
investigator believes may interact with the study drug or cause adverse events.

13. History of colonic or rectal surgery.

14. Diagnosis of diabetes, heart failure, unstable angina, liver or kidney disease, or
any other unstable medical condition.

15. Any clinically meaningful laboratory abnormality that in the judgment of the
investigator should preclude participation in the study.

16. Impaired renal function (serum creatinine levels >2.0 mg/dL) at screening.

17. Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values >1.5
times upper limit of normal at screening.

18. Diagnosis of Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter,
enteropathogenic E. coli in stool.

19. Positive test for hepatitis C virus (HCV) antibody or hepatitis B surface antigen
(HBsAg) at screening.

20. Active malignancy (except basal cell carcinoma).

21. Active alcohol or drug abuse.

22. Tobacco smoking within 6 months before study entry.
We found this trial at
Palo Alto, California 94304
Palo Alto, CA
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