Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01149707
• Date of registration: 22/06/2010
• Prospective Registration: No
• Primary sponsor: PurGenesis Technologies Inc.
• Public title: Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis
• Scientific title: A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis
• Date of first enrolment: June 1, 2010
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01149707
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Theophilus J Gana, MD, PhD
• Affiliation: Devonian Health Group Inc.

• Name: Michael Rünzi, Prof. Dr. med.
• Affiliation: Essen-Werden, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Outpatient males and females between 18 and 75 years.

2. Females of child bearing potential must have a negative serum pregnancy test
(beta-human chorionic gonadotropin) at screening and must be sexually inactive
(abstinent) for 3 months prior to dosing and throughout the study or be using one of
the following acceptable methods of contraception:

- barrier methods (condom, diaphragm with spermicide);

- Intrauterine device (IUD) in place for at least 3 months;

- surgical sterilization of the partner (vasectomy for at least 6 months); or

- hormonal contraceptives for at least 3 months prior to dosing. [Female subjects
of childbearing potential must be advised to remain sexually inactive or maintain
the same method of contraception for =7 days following the end of dosing of study
treatment]

3. Patients newly diagnosed or with ongoing active distal ulcerative colitis of >3 months
duration, confirmed by flexible sigmoidoscopy during screening, and extending 5 to 50
cm from the anal margin. Sigmoidoscopy must be conducted within not more than 3 +/- 1
days before the Baseline (Day 0) Visit.

4. Patients with ongoing active distal ulcerative colitis of =3 months duration must be
on a stable dose of oral mesalamine (5-ASA) for =2 months before the Baseline (Day 0)
Visit.

5. Modified Mayo Score (Disease Activity Index) of =5 to =10 at Baseline, including a
sigmoidoscopic inflammation grade score of =2 and a rectal bleeding score =2.

6. Negative stool test at screening to rule out parasites, bacterial pathogens and
Clostridium difficile.

7. Able and willing to fill in (maintain) daily diary cards from Day -7 to Day 21 of the
study.

8. Able to provide voluntary written informed consent prior to initiation of screening,
must be capable of following the verbal and written study instructions, and be able to
commit to the return visits during the entire period of the study.

Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic,
renal, hematological, gastrointestinal, endocrine, immunologic, dermatological,
neurological, or psychiatric disease, that could compromise patient's ability to
participate in the study, and/or interfere with absorption of the study drug or the
interpretation of the study data.

2. Patients with a diagnosis of Crohn's disease.

3. Patients with a modified Mayo score of =11 at the Screening (Day -7 & Day -3) Visits.

4. Patients at immediate or significant risk of toxic megacolon; those with bowel
stricture, colonic dysplasia, adenoma or carcinoma.

5. Use of botanical treatments and supplements for ulcerative colitis within 14 days
prior to the Baseline Visit.

6. Patients with any enteric pathogens, ova or parasites, or Clostridium difficile toxin
in stool.

7. Female patients with a positive pregnancy test or lactating at the Screening/Baseline
Visits.

8. History of allergic reaction or hypersensitivity to spinach, spinach tablet, spinach
powder or spinach extract; and to latex, molds and mushrooms.

9. History of gout, pseudogout or hyperuricemia, or kidney stones.

10. History of pseudoallergic hypersensitivity to the food color additives, tartrazine
(E102), sunset yellow (E110) and FD & C Blue No.1 (Brilliant blue FCF; E133), allergic
asthma, aspirin intolerance, and severe or multiple allergies.

11. Past medical history of significant gastrointestinal surgery including but not limited
to colostomy, ileostomy, or previous colonic surgery other than appendectomy.

12. Patients with anatomical abnormalities of the colon, e.g., short bowel or other
abnormalities.

13. Patients with any current infectious, ischemic, or immunologic disease with
gastrointestinal involvement.

14. Patients with a history of failure to retain enemas.

15. Use of antibiotics for reasons related to the primary diagnosis or for other
gastrointestinal-related conditions within 14 days of Baseline Visit.

16. Patients who used non-steroidal anti-inflammatory drugs (NSAIDs), including
cyclooxygenase-2 (COX-2) inhibitors, within 14 days prior to Baseline Visit. Except
aspirin =325 mg/day for cardiovascular prophylaxis.

17. Patients who used the following medications used for treating ulcerative colitis from
the times indicated below to the end of Week 3 (Visit 6):

- Topical intrarectal corticosteroids or topical intrarectal mesalamine within 14
days of Baseline Visit;

- Systemic corticosteroids (oral or injectable, including adrenocorticotropic
hormone [ACTH]) within 30 days of Baseline Visit;

- Immunosuppressant therapy (methotrexate, azathioprine, 6-mercatopurine or
cyclosporine) within 60 days of Baseline Visit; and

- Biologic therapy (tumor necrosis factor-a inhibitors, monoclonal antibodies,
etc.) within 90 days of Baseline Visit.

18. Patients with a history of active malignancy within the past 5 years except for
squamous cell or basal cell cancers of the skin.

19. History of any clinical laboratory abnormality deemed significant by the Principal
Investigator.

20. History of significant alcohol or drug abuse within one year prior to the Screening
Visit.

21. Patients who tested positive at Screening for human immunodeficiency virus (HIV),
hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).

22. Exposure to any investigational or non-registered drug within 30 days prior to
administration of study drug.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Left-Sided Ulcerative Colitis

Proctosigmoiditis

Intervention(s)

Drug: PUR 0110 Rectal Enema 1000 mg

Drug: PUR 0110 Rectal Enema 250 mg

Drug: Placebo Enema

Drug: PUR 0110 Rectal Enema 500 mg

Primary Outcome(s)

Number of patients with treatment-related adverse events [Time Frame: At Week 2]

Secondary Outcome(s)

Effect of PUR0110 on biomarkers of inflammation [Time Frame: At week 2]

Effectiveness of PUR0110 on remission rate [Time Frame: At week 2]

Effectiveness of PUR0110 on subject response and remission rate [Time Frame: At week 2]

Effectiveness of PUR0110 on overall Mayo score [Time Frame: At week 2]

Effectiveness of PUR0110 on proportion of subjects with treatment failure defined as unchanged, worsened or missing modified Mayo score [Time Frame: At week 2]

Effect of PUR0110 on C-reactive Protein (CRP), high sensitivity CRP (hsCRP), erythrocyte sedimentation rate (ESR), Fecal Falprotectin (FCP) and Fecal Lactoferrin (FL) compared to placebo [Time Frame: At week 2]

Effect of PUR0110 on M30 apoptosome in serum and biopsies [Time Frame: At week 2]

Effectiveness of PUR0110 on clinical response rate [Time Frame: At week 2]

Effectiveness of PUR0110 on in each of the 4 individual sub-scores of the modified Mayo score. [Time Frame: At week 2]

Effectiveness of PUR0110 on investigator assessment of ulcerative colitis symptom score [Time Frame: At week 2]

Effect of PUR0110 on M65 apoptosome in serum and biopsies [Time Frame: At week 2]

Effectiveness of PUR0110 on inflammatory bowel disease questionnaire (IBDQ) score [Time Frame: At week 2]

Secondary ID(s)

PG09 PUR 0210 002

29PS1617

2009 017839 18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors