Ulcerative ColitisPhase 2NCT01216280
Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
A Phase 2 study testing 2 x 10 mg Natura-alpha capsules in people with Ulcerative Colitis, run by Natrogen Therapeutics International, Inc at 10 sites in United States.
Trial summary
This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind, placebo-controlled, parallel-design study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- 2 x 10 mg Natura-alpha capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 10 sitesUnited States
- Study dates
- Jul 2010to Sep 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods.
- Subject is require to meet one of the following criteria:
- Newly diagnosed patients with moderate to severe ulcerative colitis evidenced by endoscopy and histopathology, who have never been medically treated for ulcerative colitis, or
- Patients with moderate to severe disease, as defined by a Disease Activity Index (DAI) score of 6-10 (inclusive) at the Baseline Visit (assessed at screening and verified at Day 1), with a negative evaluation of the terminal ileum within 3 years of the screening visit, or
- Patients with active ulcerative colitis who are refractory or intolerant to therapies of 5-ASA, steroids, immunosuppressants or anti-TNF-alpha.
- Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy, with a DAI mucosal appearance sub score ≥ 2.
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- DAI rectal bleeding sub score of ≥ 1.
- Physician's Global Assessment (PGA) DAI sub score ≥ 2.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Ability to provide voluntary written informed consent.
- Adequate cardiac, renal and hepatic function as determined by site principal investigator and demonstrated by screening laboratory evaluations, and questionnaires, and physical examination results that are within normal limits.
Who cannot join
- History of colonic or rectal surgery.
- Pregnant or breast-feeding.
- Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, or any other unstable medical condition.
- Known hypersensitivity to Natura alpha or any of the drug excipients.
- Active and chronic infections.
- Severe ulcerative colitis indicated by Disease Activity Index score > 10.
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- Patients with ulcerative proctitis (disease limited to less than 15 cm from the anal verge).
- Use of any vaccine or any other immunostimulator within 4 weeks prior to the screening visit. .
- Use of > 2.4 gm mesalamine or equivalent within 2 weeks prior to the screening visit.
- Use of oral corticosteroids for more than 3 days during the two weeks prior to the screening visit.
- Use of corticosteroid or 5-ASA enemas, foams, or suppositories at any time within two weeks prior to the screening visit. .
- Use of TNF-alpha antibody or any other biologic therapy within 2 months prior to the screening visit. .
- Use of immunosuppressive drugs at any time within four weeks prior to the screening visit. .
- Use of oral or parenteral antibiotics at any time within two weeks prior to the screening visit.
- Diagnosis of Crohn's disease.
- Diagnosis of indeterminate colitis (inability to distinguish between ulcerative colitis and Crohn's disease).
- Diagnosis of microscopic colitis (collagenous or lymphocytic colitis).
- Diagnosis of ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis, or gonococcal proctitis.
- Diagnosis of Clostridium difficile colitis.
- History of positive serology to hepatitis B or C or human immunodeficiency virus (HIV) infection.
- Active alcohol or drug abuse.
- Known malignancy or history of malignancy that would reduce life expectancy.
- Current smoker, or has been a smoker within 6 months prior to the screening visit.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20814
Consultants for Clinical Research
Cincinnati, Ohio, 45219
AGA Medical Research Associates, LLC
Egg Harbor, New Jersey, 08324
Consultants for Clinical Research
Fairfield, Ohio, 45014
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Wisconsin Center for Advanced Research, LLC
Milwaukee, Wisconsin, 53215
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
About this study
This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo, Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending Sponsor approval, if it appears that less than 60 patients will complete the study.
Read the detailed description
This will be a randomized, double-blind, placebo-controlled, parallel-design study. Eligible patients will have moderate to severe ulcerative colitis, defined as:
- A Disease Activity Index (DAI) score of 6 to 10 (inclusive);
- Endoscopic evidence of active ulcerative colitis (DAI mucosal appearance sub score of ≥2) as assessed by flexible sigmoidoscopy unless colonoscopy is clinically indicated;
- Rectal bleeding (DAI sub score of ≥1);
- Physician's Global Assessment (PGA) of moderate disease (DAI sub score ≥2). Patients will be randomized to receive placebo, 10 mg Natura-alpha or 20 mg Natura-alpha. Patients will self-administer their assigned dose orally for 28 consecutive days, twice per day (b.i.d) at approximately 8:00 am and 8:00 pm.
The effectiveness and safety of Natura-alpha will be evaluated at baseline, and after 7, 14 and 28 days of treatment. Additional follow-up measurements will take place 7 and 28 days post cessation of treatment (Day 35 and Day 56, respectively). Stool samples for fecal calprotectin (FC) tests and optional blood samples (15 ml) for cytokine tests will be collected and analyzed at sponsor-selected sites and lab for exploratory analyses to be performed at a later date.
Clinical response will be assessed by the Physician's Global Assessment (PGA) on the basis of sigmoidoscopy (Walkiewicz, Werlin et al. 2008) and mucosal appearance (DAI category). Sigmoidoscopy including histopathological examination to assess disease severity and changes in tissue inflammation will be conducted before and after treatment (Day 1, Day 28) by the same endoscopist at each site and read by one sponsor selected central pathologist. Truelove-Richards histological grading system will be applied for disease histological scoring (Pullan, Rhodes et al. 1994; Zhong, Huang et al. 2005; Liang and Ouyang 2008). Safety labs and adverse events (AEs) will be monitored for the duration of the study (including the 7 day follow up visit).
- Conditions
- Ulcerative Colitis
- Being tested
- placebo capsule, 10 mg Natura-alpha capsule and 10 mg placebo capsule, 2 x 10 mg Natura-alpha capsules
- Keywords
- Natura-alpha, ulcerative colitis, cytokines, Th1, Th17
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo capsuleDrug
Also called Group 1
2 x 10 mg placebo capsules administered orally with water, b.i.d.
10 mg Natura-alpha capsule and 10 mg placebo capsuleDrug
Also called Group 2
10 mg Natura-alpha capsule and 10 mg placebo capsule administered orally with water, b.i.d.
2 x 10 mg Natura-alpha capsulesDrug
Also called Group 3
2 x 10mg Natura-alpha capsules administered orally with water, b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| 2 x 10 mg placebo capsule | Placebo comparator | 2 x 10 mg placebo capsules, administered orally with water, b.i.d. Receives: Drug: placebo capsule |
| 10mg Natura-alpha + 10 mg placebo | Experimental | 10 mg Natura-alpha capsule + 10 mg placebo capsule administered orally with water, b.i.d. Receives: Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule |
| 2 x 10 mg Natura-alpha capsules | Experimental | 2 x 10mg Natura-alpha capsules administered orally with water, b.i.d. Receives: Drug: 2 x 10 mg Natura-alpha capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's Global Assessment(PGA)
The primary efficacy endpoint will be the proportion of patients in all treatment groups with clinical response (improvement) at Day 28.
Measured: Day 28 after the treatment
Secondary outcomes (5)
Physician's Global Assessment (PGA)
The proportion of patients in all treatment groups who achieve clinical remission at Day 28
Measured: Day 28 after the treatment
Physician's Global Assessment (PGA)
The proportion of patients in all treatment groups who demonstrate clinical response
Measured: Day 7
Physician's Global Assessment (PGA)
The proportion of patients in all treatment groups who demonstrate clinical response
Measured: 14
Physician's Global Assessment (PGA)
The proportion of patients in all treatment groups who demonstrate clinical response who were previously corticosteroid, 5-aminosalicylic acid (5-ASA), immunosuppresant, TNF-alpha antibody therapy-refractory or intolerant
Measured: Day 28
Safety
adverse events, changes in physical examination findings, vital signs, concomitant medications, and laboratory test results
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natrogen Therapeutics International, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Longgui Wang, MD, Study director, Natrogen Therapeutics International, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216280
- Sponsor's protocol ID
- NTI-2009-UC1
- Other IDs
- 70984
- Status last verified
- Jul 2010
- First submitted
- 2 Sep 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01216280
- Acronym / sponsor ID
- NTI-2009-UC1
- Conditions
- Ulcerative Colitis
- Keywords
- Natura-alpha, ulcerative colitis, cytokines, Th1, Th17
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Natrogen Therapeutics International, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 7 Oct 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.
This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo, Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending Sponsor approval, if it appears that less than 60 patients will complete the study.
Detailed description
This will be a randomized, double-blind, placebo-controlled, parallel-design study. Eligible patients will have moderate to severe ulcerative colitis, defined as:
- A Disease Activity Index (DAI) score of 6 to 10 (inclusive);
- Endoscopic evidence of active ulcerative colitis (DAI mucosal appearance sub score of ≥2) as assessed by flexible sigmoidoscopy unless colonoscopy is clinically indicated;
- Rectal bleeding (DAI sub score of ≥1);
- Physician's Global Assessment (PGA) of moderate disease (DAI sub score ≥2). Patients will be randomized to receive placebo, 10 mg Natura-alpha or 20 mg Natura-alpha. Patients will self-administer their assigned dose orally for 28 consecutive days, twice per day (b.i.d) at approximately 8:00 am and 8:00 pm.
The effectiveness and safety of Natura-alpha will be evaluated at baseline, and after 7, 14 and 28 days of treatment. Additional follow-up measurements will take place 7 and 28 days post cessation of treatment (Day 35 and Day 56, respectively). Stool samples for fecal calprotectin (FC) tests and optional blood samples (15 ml) for cytokine tests will be collected and analyzed at sponsor-selected sites and lab for exploratory analyses to be performed at a later date.
Clinical response will be assessed by the Physician's Global Assessment (PGA) on the basis of sigmoidoscopy (Walkiewicz, Werlin et al. 2008) and mucosal appearance (DAI category). Sigmoidoscopy including histopathological examination to assess disease severity and changes in tissue inflammation will be conducted before and after treatment (Day 1, Day 28) by the same endoscopist at each site and read by one sponsor selected central pathologist. Truelove-Richards histological grading system will be applied for disease histological scoring (Pullan, Rhodes et al. 1994; Zhong, Huang et al. 2005; Liang and Ouyang 2008). Safety labs and adverse events (AEs) will be monitored for the duration of the study (including the 7 day follow up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 x 10 mg placebo capsule | Placebo comparator | Drug: placebo capsule2 x 10 mg placebo capsules, administered orally with water, b.i.d. |
| 10mg Natura-alpha + 10 mg placebo | Experimental | Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule10 mg Natura-alpha capsule + 10 mg placebo capsule administered orally with water, b.i.d. |
| 2 x 10 mg Natura-alpha capsules | Experimental | Drug: 2 x 10 mg Natura-alpha capsules2 x 10mg Natura-alpha capsules administered orally with water, b.i.d. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods.
- Subject is require to meet one of the following criteria:
- Endoscopic evidence of active mucosal disease as assessed by flexible sigmoidoscopy, with a DAI mucosal appearance sub score ≥ 2.
- DAI rectal bleeding sub score of ≥ 1.
- Physician's Global Assessment (PGA) DAI sub score ≥ 2.
Key exclusion criteria (23 listed)
- History of colonic or rectal surgery.
- Pregnant or breast-feeding.
- Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, or any other unstable medical condition.
- Known hypersensitivity to Natura alpha or any of the drug excipients.
- Active and chronic infections.
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 |
|---|---|---|
| placebo capsuleAlso: Group 12 x 10 mg placebo capsules administered orally with water, b.i.d. | Drug | 2 x 10 mg placebo capsule |
| 10 mg Natura-alpha capsule and 10 mg placebo capsuleAlso: Group 210 mg Natura-alpha capsule and 10 mg placebo capsule administered orally with water, b.i.d. | Drug | 10mg Natura-alpha + 10 mg placebo |
| 2 x 10 mg Natura-alpha capsulesAlso: Group 32 x 10mg Natura-alpha capsules administered orally with water, b.i.d. | Drug | 2 x 10 mg Natura-alpha capsules |
Primary outcome
Physician's Global Assessment(PGA)
Time frame: Day 28 after the treatment
The primary efficacy endpoint will be the proportion of patients in all treatment groups with clinical response (improvement) at Day 28.
5 secondary outcomes
Physician's Global Assessment (PGA)
Time frame: Day 28 after the treatment
Physician's Global Assessment (PGA)
Time frame: Day 7
Physician's Global Assessment (PGA)
Time frame: 14
Physician's Global Assessment (PGA)
Time frame: Day 28
Safety
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Longgui Wang, MD study director
Natrogen Therapeutics International, Inc
10 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 2 x 10 mg Natura-alpha capsules in people with Ulcerative Colitis, run by Natrogen Therapeutics International, Inc at 10 sites in United States.
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 11 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Results are not available in the source record.
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?
Physician's Global Assessment(PGA) (time frame: Day 28 after the treatment). 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 27 Jun 2011.