Track topics on Twitter Track topics that are important to you
PUR 0110 is a 100% natural novel investigational medicinal product that has been demonstrated in several in vitro and in vivo pharmacology studies to have potent anti-inflammatory, anti-oxidative and immunomodulatory effects. This exploratory Phase 2a study is a first-in-patient study to evaluate the safety, tolerability, biomarker effect and efficacy of PUR 0110 rectal enema in patients with active mild-to-moderate distal ulcerative colitis (UC).
The study is a multicenter, randomized, double-blind, parallel-group, dose-ranging, placebo-controlled study. To be eligible for inclusion into the study, patients must either be newly diagnosed or have on-going active mild-to-moderate distal ulcerative colitis of at least 3 months duration confirmed in either case by flexible sigmoidoscopy and biopsy at the Screening Visit. In addition, patients must have a modified Mayo score of ≥5 to ≤10 including a sigmoidoscopy inflammation grade and rectal bleeding scores of ≥2 each. Eligible patients will be randomly assigned to receive either PUR 0110 250 mg, 500 mg or 1000 mg or placebo rectal enema in a 1:1:1:1 ratio. Patients will self-administer the assigned study medication intrarectally once-daily at bedtime (10:00 p.m +/- 1 hour) for 2 weeks.
Patients will be evaluated for safety by adverse events, clinical laboratory tests, vital signs, physical examination, electrocardiogram (ECG), and concomitant medications. Efficacy evaluations will include the modified Mayo score, patient-defined response and remission, Investigator Assessment of Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease Questionnaire (IBDQ), and biomarkers of inflammation, apoptosis and total cell death, lipid peroxidation and in vivo oxidative stress, and antioxidant defense mechanisms in plasma, serum, urine, feces and biopsy tissue. Patients will have a flexible sigmoidoscopy and biopsy 12 hours after the last dose of study medication.
Safety/Primary Outcome Parameters:
- Incidence, nature and severity of adverse events
- Incidence, nature and severity of clinical laboratory test abnormalities
Efficacy/Secondary Outcome Parameters:
- Clinical remission defined as an endoscopy score of ≤ 1, a rectal bleeding score of 0, and an improvement or no change from baseline in the stool frequency score at the end of 2 weeks of treatment / withdrawal visit;
- Clinical response rate defined as the percentage of patients with a drop of ≥3 points from the baseline overall modified Mayo score;
- Patient defined response and remission rates;
- Change from baseline in the overall modified Mayo score (Disease Activity Index);
- Change from baseline in each of the 4 individual sub-scores of the modified Mayo score;
- Change from baseline in Investigator Assessment of UC Symptom Score (total and individual symptom scores)
- Change from baseline in IBDQ score (total and the 4 individual dimension scores)
- Proportion of patients with treatment failure;
- Change from baseline in serum lutein levels;
- Change from baseline in C-reactive protein (CRP), high sensitivity CRP (hs-CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP), and fecal lactoferrin (FL).
- Change from baseline in exploratory biomarkers including: serum interleukin-2 (IL-2), IL-6, IL-8, interferon-gamma (IFN-gamma), tumor necrosis factor-alpha (TNF-α), transforming growth factor-beta (TGF-beta), IL-4, IL-10, IL-17, IL-23, human beta-Defensin-2 (hBD-2), malondialdehyde (MDA), lipoxin A4 (LXA4), glutathione (GSH), M30 and M65 apoptosomes in serum and biopsies, and plasma and urinary isoprostane levels.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Left-Sided Ulcerative Colitis
PUR 0110 Rectal Enema 250 mg, PUR 0110 Rectal Enema 500 mg, PUR 0110 Rectal Enema 1000 mg, Placebo Enema
PurGenesis Investigational Site
PurGenesis Technologies Inc.
Published on BioPortfolio: 2014-08-27T03:12:42-0400
The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa...
The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subject...
In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be free of solid matter so the endoscopist has a clear view, increasing the chance of detection o...
Microbicides are drugs that destroy microbes such as viruses and bacteria. Rectal microbicides may be able to prevent transmission of HIV during anal intercourse. The purpose of this study...
The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and ...
Maternal rectal enemas may reduce neonatal bacterial exposure during labour; this may reduce the risk of neonatal colonization with Clostridium difficile. The aim of this study was to determine the ef...
In 2012, the American Society of Colon and Rectal Surgeons published the Rectal Cancer Surgery Checklist, a consensus document listing 25 essential elements of care for all patients undergoing radical...
Rectal injuries have been historically treated with a combination of modalities including direct repair, resection, proximal diversion, presacral drainage, and distal rectal washout. We hypothesized t...
Obtaining a patient's temperature is an important part of a patient's physical examination. As human medicine transitions to noninvasive temperature measurements, so does veterinary medicine. Historic...
Measuring rectal temperature in children is the gold standard, but ear or forehead measures are less traumatic and faster. The quality of non-invasive devices has improved but concerns remain whether ...
A compound tubular gland, located around the eyes and nasal passages in marine animals and birds, the physiology of which figures in water-electrolyte balance. The Pekin duck serves as a common research animal in salt gland studies. A rectal gland or rectal salt gland in the dogfish shark is attached at the junction of the intestine and cloaca and aids the kidneys in removing excess salts from the blood. (Storer, Usinger, Stebbins & Nybakken: General Zoology, 6th ed, p658)
Protrusion of the rectal mucous membrane through the anus. There are various degrees: incomplete with no displacement of the anal sphincter muscle; complete with displacement of the anal sphincter muscle; complete with no displacement of the anal sphincter muscle but with herniation of the bowel; and internal complete with rectosigmoid or upper rectum intussusception into the lower rectum.
Uptake of substances from the RECTUM.
Tumors or cancer of the RECTUM.
Procedure involving the instillation of an anesthetic into the rectum.