Left-Sided Ulcerative ColitisPhase 2NCT01149707
Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis
A Phase 2 study testing PUR 0110 Rectal Enema 250 mg, PUR 0110 Rectal Enema 500 mg and PUR 0110 Rectal Enema 1000 mg in people with Left-Sided Ulcerative Colitis and Proctosigmoiditis, run by PurGenesis Technologies Inc. at 6 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Left-Sided Ulcerative Colitis, Proctosigmoiditis
- What is being tested?
- PUR 0110 Rectal Enema 250 mg, PUR 0110 Rectal Enema 500 mg and PUR 0110 Rectal Enema 1000 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 6 sitesGermany
- Study dates
- 1 Jun 2010to 20 Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient males and females between 18 and 75 years.
- 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]
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- 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.
- 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.
- 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.
- Negative stool test at screening to rule out parasites, bacterial pathogens and Clostridium difficile.
- Able and willing to fill in (maintain) daily diary cards from Day -7 to Day 21 of the study.
- 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.
Who cannot join
- 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.
- Patients with a diagnosis of Crohn's disease.
- Patients with a modified Mayo score of ≥11 at the Screening (Day -7 \& Day -3) Visits.
- Patients at immediate or significant risk of toxic megacolon; those with bowel stricture, colonic dysplasia, adenoma or carcinoma.
- Use of botanical treatments and supplements for ulcerative colitis within 14 days prior to the Baseline Visit.
- Patients with any enteric pathogens, ova or parasites, or Clostridium difficile toxin in stool.
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- Female patients with a positive pregnancy test or lactating at the Screening/Baseline Visits.
- History of allergic reaction or hypersensitivity to spinach, spinach tablet, spinach powder or spinach extract; and to latex, molds and mushrooms.
- History of gout, pseudogout or hyperuricemia, or kidney stones.
- 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.
- Past medical history of significant gastrointestinal surgery including but not limited to colostomy, ileostomy, or previous colonic surgery other than appendectomy.
- Patients with anatomical abnormalities of the colon, e.g., short bowel or other abnormalities.
- Patients with any current infectious, ischemic, or immunologic disease with gastrointestinal involvement.
- Patients with a history of failure to retain enemas.
- Use of antibiotics for reasons related to the primary diagnosis or for other gastrointestinal-related conditions within 14 days of Baseline Visit.
- 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.
- 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-α inhibitors, monoclonal antibodies, etc.) within 90 days of Baseline Visit.
- Patients with a history of active malignancy within the past 5 years except for squamous cell or basal cell cancers of the skin.
- History of any clinical laboratory abnormality deemed significant by the Principal Investigator.
- History of significant alcohol or drug abuse within one year prior to the Screening Visit.
- Patients who tested positive at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV).
- Exposure to any investigational or non-registered drug within 30 days prior to administration of study drug.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
PurGenesis Investigational Site
Jena, 07740
PurGenesis Investigational Site
Köln-Merheim, 51109
PurGenesis Investigational Site
Ludwigshafen, 67067
PurGenesis Investigational Site
Minden, 32423
PurGenesis Investigational Site
Oelde, 59302
PurGenesis Investigational Site
Werden, 45239
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Left-Sided Ulcerative Colitis, Proctosigmoiditis
- Being tested
- PUR 0110 Rectal Enema 250 mg, PUR 0110 Rectal Enema 500 mg, PUR 0110 Rectal Enema 1000 mg, Placebo Enema
- Keywords
- PUR 0110, PUR 0110 Rectal Enema, Distal Ulcerative Colitis, Left-Sided Ulcerative Colitis, Mild, Moderate
- Medical subject headings
- Proctocolitis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUR 0110 Rectal Enema 250 mgDrug
Also called Active treatment arm
PUR 0110 Rectal Enema 250 mg, once-daily, intrarectally
PUR 0110 Rectal Enema 500 mgDrug
Also called Active treatment arm
PUR 0110 Rectal Enema 500 mg, once-daily, intrarectally
PUR 0110 Rectal Enema 1000 mgDrug
Also called Active treatment arm
PUR 0110 Rectal Enema 1000 mg, once-daily, intrarectally
Placebo EnemaDrug
Also called Placebo arm
Placebo Enema, once-daily, intrarectally
| Study group | Role | What they receive |
|---|---|---|
| PUR 0110 Rectal Enema 250 mg | Experimental | Active treatment Receives: Drug: PUR 0110 Rectal Enema 250 mg |
| PUR 0110 Rectal Enema 500 mg | Experimental | Active treatment Receives: Drug: PUR 0110 Rectal Enema 500 mg |
| PUR 0110 Rectal Enema 1000 mg | Experimental | Active treatment Receives: Drug: PUR 0110 Rectal Enema 1000 mg |
| Placebo Enema | Placebo comparator | Placebo comparator Receives: Drug: Placebo Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment-related adverse events
Safety \& Tolerability of PUR0110 rectal enema compared to placebo as per Incidence, nature and severity of adverse events (AEs); and abnormal clinical laboratory test results.
Measured: At Week 2
Secondary outcomes (12)
Effectiveness of PUR0110 on remission rate
Effectiveness of PUR0110 compared to placebo as per Clinical remission rate with 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.
Measured: At week 2
Effectiveness of PUR0110 on clinical response rate
Effectiveness of PUR0110 compared to placebo as per : Clinical response rate defined as the percentage of subjects with a drop of ≥3 points from the baseline overall modified Mayo score.
Measured: At week 2
Effectiveness of PUR0110 on subject response and remission rate
Effectiveness of PUR0110 compared to placebo as per Subject defined response and remission rates based on their well being : 1= much better; 2= some better; 3=a little better; 4= about the same; 5=a little worse; 6= some worse \& 7= much worse.ed as : o= none; 1 = mild; 2=moderate, 3=severe and 4 = incapacitating.
Measured: At week 2
Effectiveness of PUR0110 on overall Mayo score
Effectiveness of PUR0110 compared to placebo as per Change from baseline in the overall modified Mayo score.
Measured: At week 2
Effectiveness of PUR0110 on in each of the 4 individual sub-scores of the modified Mayo score.
Effectiveness of PUR0110 compared to placebo as per Change from baseline in each of the 4 individual sub-scores of the modified Mayo score.
Measured: At week 2
Effectiveness of PUR0110 on investigator assessment of ulcerative colitis symptom score
Effectiveness of PUR0110 compared to placebo as per Change from baseline in investigator assessment of ulcerative colitis symptom score : 0= none; 1= Mild; 2=Moderate; 3=Severe and 4 = incapacitating
Measured: At week 2
Effectiveness of PUR0110 on inflammatory bowel disease questionnaire (IBDQ) score
Effectiveness of PUR0110 compared to placebo as per Change from baseline in inflammatory bowel disease questionnaire (IBDQ) score.
Measured: At week 2
Effectiveness of PUR0110 on proportion of subjects with treatment failure defined as unchanged, worsened or missing modified Mayo score
Effectiveness of PUR0110 compared to placebo as per : Proportion of subjects with treatment failure;
Measured: At week 2
Effect of PUR0110 on biomarkers of inflammation
Change from baseline in exploratory biomarkers - serum IL-2, IL-6, IL8, IFN-γ, TNF-α, TGF-β, IL-4, IL-10, IL-17, IL-23, hβD-2, MDA, LXA4, GSH and LTB4 levels in serum and biopsies; plasma and urinary isoprostane levels and serum lipoxin A4 levels..
Measured: 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
Change from baseline in CRP, hs-CRP, ESR, FCP and FL .
Measured: At week 2
Effect of PUR0110 on M30 apoptosome in serum and biopsies
Effect of PUR0110 on M30 apoptosome in serum and biopsies compared to placebo
Measured: At week 2
Effect of PUR0110 on M65 apoptosome in serum and biopsies
Effect of PUR0110 on M65 apoptosome in serum and biopsies compared to placebo
Measured: At week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study start1 Jun 2010
- Primary completion1 Oct 2014
- Study completion20 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left-Sided Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- PurGenesis Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theophilus J Gana, MD, PhD, Study director, Devonian Health Group Inc.Michael Rünzi, Prof. Dr. med., Principal investigator, Essen-Werden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149707
- Sponsor's protocol ID
- PG09 PUR 0210 002
- Other IDs
- 2009 017839 18, 29PS1617, 2009
- Status last verified
- Apr 2018
- First submitted
- 22 Jun 2010
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01149707
- Acronym / sponsor ID
- PG09 PUR 0210 002
- Conditions
- Left-Sided Ulcerative Colitis, Proctosigmoiditis
- Keywords
- PUR 0110, PUR 0110 Rectal Enema, Distal Ulcerative Colitis, Left-Sided Ulcerative Colitis, Mild, Moderate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PurGenesis Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2010
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 20 Jun 2015 (actual)
- First posted
- 23 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PUR 0110 Rectal Enema 250 mg | Experimental | Drug: PUR 0110 Rectal Enema 250 mgActive treatment |
| PUR 0110 Rectal Enema 500 mg | Experimental | Drug: PUR 0110 Rectal Enema 500 mgActive treatment |
| PUR 0110 Rectal Enema 1000 mg | Experimental | Drug: PUR 0110 Rectal Enema 1000 mgActive treatment |
| Placebo Enema | Placebo comparator | Drug: Placebo EnemaPlacebo comparator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Outpatient males and females between 18 and 75 years.
- 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:
- 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.
- 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.
- 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.
Key exclusion criteria (26 listed)
- 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.
- Patients with a diagnosis of Crohn's disease.
- Patients with a modified Mayo score of ≥11 at the Screening (Day -7 \& Day -3) Visits.
- Patients at immediate or significant risk of toxic megacolon; those with bowel stricture, colonic dysplasia, adenoma or carcinoma.
- Use of botanical treatments and supplements for ulcerative colitis within 14 days prior to the Baseline Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUR 0110 Rectal Enema 250 mgAlso: Active treatment armPUR 0110 Rectal Enema 250 mg, once-daily, intrarectally | Drug | PUR 0110 Rectal Enema 250 mg |
| PUR 0110 Rectal Enema 500 mgAlso: Active treatment armPUR 0110 Rectal Enema 500 mg, once-daily, intrarectally | Drug | PUR 0110 Rectal Enema 500 mg |
| PUR 0110 Rectal Enema 1000 mgAlso: Active treatment armPUR 0110 Rectal Enema 1000 mg, once-daily, intrarectally | Drug | PUR 0110 Rectal Enema 1000 mg |
| Placebo EnemaAlso: Placebo armPlacebo Enema, once-daily, intrarectally | Drug | Placebo Enema |
Primary outcome
Number of patients with treatment-related adverse events
Time frame: At Week 2
Safety \& Tolerability of PUR0110 rectal enema compared to placebo as per Incidence, nature and severity of adverse events (AEs); and abnormal clinical laboratory test results.
12 secondary outcomes
Effectiveness of PUR0110 on remission rate
Time frame: At week 2
Effectiveness of PUR0110 on clinical response 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 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
Effectiveness of PUR0110 on inflammatory bowel disease questionnaire (IBDQ) 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 biomarkers of inflammation
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
Effect of PUR0110 on M65 apoptosome in serum and biopsies
Time frame: At week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theophilus J Gana, MD, PhD study director
Devonian Health Group Inc.
Michael Rünzi, Prof. Dr. med. principal investigator
Essen-Werden, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PUR 0110 Rectal Enema 250 mg, PUR 0110 Rectal Enema 500 mg and PUR 0110 Rectal Enema 1000 mg in people with Left-Sided Ulcerative Colitis and Proctosigmoiditis, run by PurGenesis Technologies Inc. at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment-related adverse events (time frame: At Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.