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Ulcerative ColitisPhase 2NCT01586533

Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

A Phase 2 study testing Zoenasa-1:4 and Mesalamine Enema in people with Ulcerative Colitis and Left-sided Ulcerative Colitis, run by Altheus Therapeutics, Inc. at 45 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of… Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Zoenasa-1:4 and Mesalamine Enema
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
45 sitesUnited States
Study dates
Jun 2012to Apr 2014
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female subjects are eligible if they are ≥ 18 years of age and ≤ 64 years.
  • They have a documented history of idiopathic ulcerative colitis based on endoscopic and/or histologic findings involving the left side of the colon, with mild to moderate active disease.
  • Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI score of 4-10, inclusive, with a Physician's rating of disease score of 2 points or less (mild or moderate active ulcerative colitis), rectal bleeding score of 1 or more (based on subject diary), and mucosal appearance score (based on endoscopy) of 1 point or more at baseline.
  • Laboratory data:
  • White blood cell count between 4.0 - 12.0 K/mm3
  • Platelet count: 150 - 500 K/mm3
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  • Hemoglobin > 10.0 g/dL
  • Total bilirubin < 1.5 mg/dL
  • Aspartate aminotransferase < 100 u/dL
  • Alanine aminotransferase < 100 u/dL
  • Alkaline phosphatase < 250 u/dL
  • Blood urine nitrogen < 40 mg/dL
  • Creatinine < 1.5 mg/dL
  • Satisfies one of the following:
  • Female subjects of childbearing potential must have a negative urine pregnancy test at screening; surgically sterile, post-menopausal, abstinent, or patient or partner agree to use a medically appropriate form of birth control from screening to until 1 month after the last dose of study medication.
  • Male subjects must be surgically sterile, abstinent, or patient or partner compliant with a contraceptive regimen from screening to until 1 month after the last dose of study medication.
  • They are able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Who cannot join

  • They have documented history of proximal or universal ulcerative colitis, proctitis or active proctitis confined to 15cm or less from the anal verge.
  • They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
  • They receive a Physician's rating of disease severity as part of the modified UCDAI of 3 (severe disease) or an aggregate score of 11 or greater.
  • They have shown prior documented history of evidence of high grade dysplasia on biopsy from endoscopic examinations.
  • Their stool contains enteric pathogens or Clostridium difficile toxins.
  • They have a history of recurrent Clostridium difficile infection.
Show all 19Show fewer
  • They have prior history of biologic therapy within the previous 4 years.
  • They have received systemic steroids or immunosuppressants within the previous 4 weeks.
  • Treatment in the last 14 days that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) or mesalamine enema (Rowasa®).
  • Treatment in the last 7 days that included mesalamine (5-ASA) via oral administration (e.g. Asacol®, Lialda®, balsalazide, etc).
  • They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
  • Positive pregnancy test or lactating subjects.
  • There is evidence of chemical substance abuse.
  • They have had repeated anti-inflammatory drug treatment (longer than 3 days at doses that exceed those available without a prescription) within the previous 7 days (with exception of aspirin at doses of 325mg/day or less for prophylaxis of cardiac disease), or initiated new non-steroidal anti-inflammatory (NSAID) treatment within the last 30 days.
  • They have a known allergy to N-acetylcysteine or mesalamine, or have a history of serious AEs related to their use (including, but not limited to pancreatitis or hepatitis).
  • They have a history of failure to retain enemas.
  • Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
  • Use of any investigational medication within the previous 90 days.
  • Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

United States45 sites

  • NCH Medical Group

    Arlington Heights, Illinois, 60004

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Tri-County Research

    Athens, Georgia, 30606

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Dr. Jason Bozdin, M.D.

    Berkley, Michigan, 48072

  • Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • Greater Cincinnati Gastroenterology

    Cincinnati, Ohio, 45219

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa, 52807

  • Carolina Digestive Health Associates

    Davidson, North Carolina, 28036

  • The Atlanta Center for Gastroenterology

    Decatur, Georgia, 30033

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Digestive Disease Associates

    Gainesville, Florida, 32605

  • Gastro One

    Germantown, Tennessee, 38138

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • LeBauer Research Associates, P.A.

    Greensboro, North Carolina, 27403

  • Digestive Medical Associates

    Hialeah, Florida, 33016

  • The Center for Gastrointestinal Disorders

    Hollywood, Florida, 33021

  • Houston Digestive Disease Clinic

    Houston, Texas, 77090

  • GI Associates and Endoscopy Center

    Jackson, Mississippi, 39202

  • Rocky Mountain Gastroenterology

    Lakewood, Colorado, 80214

  • Clinical Trials Management of Louisiana

    Metairie, Louisiana, 70006

  • Miami Gastroenterology Consultants P.A.

    Miami, Florida, 33156

  • South Medical Research Group

    Miami, Florida, 33186

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Gastroenterology of Naples

    Naples, Florida, 34102

  • Research Associates of New York

    New York, New York, 10028

  • Digestive & Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73104

  • Advanced Gastroenterology Associates

    Palm Harbor, Florida, 34684

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Digestive Health Associates of Texas

    Plano, Texas, 75075

  • St. Josephs Candler Health System

    Savannah, Georgia, 31405

  • Digestive Disease Institute

    Seattle, Washington, 98101

  • Advanced Research Institute

    South Ogden, Utah, 84405

  • Franciscan Research Center

    Tacoma, Washington, 98405

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Gastroenterology United Tulsa

    Tulsa, Oklahoma, 74135

  • Professional Research Network of Kansas

    Wichita, Kansas, 67203

  • Shafran Gastroenterology

    Winter Park, Florida, 32789

  • Gregory Cammel, MD PLC

    Wyoming, Michigan, 48418

Other trials in United States

About this study

Official title: A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis

This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.

Being tested
Zoenasa-1:4, Mesalamine Enema
Keywords
ulcerative colitis, UC, left-sided ulcerative colitis, distal ulcerative colitis, Zoenasa, mesalamine, mesalazine, 5-ASA, 5-aminosalicylic acid, N-acetylcysteine, acetylcysteine, NAC, enema, rectal gel
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zoenasa-1:4Drug

    Zoenasa Rectal Gel (4.0g mesalamine [5-ASA], 1.0g N-acetylcysteine [NAC]; 60ml)

  • Mesalamine EnemaDrug

    Mesalamine Rectal Suspension Enema (4.0g mesalamine [5-ASA], 60ml)

Study groups in NCT01586533
Study groupRoleWhat they receive
Zoenasa-1:4ExperimentalNot described
Receives: Drug: Zoenasa-1:4
Mesalamine EnemaActive comparatorNot described
Receives: Drug: Mesalamine Enema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in modified UCDAI at 6 weeks

    Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 6 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine

    Measured: 6 weeks

Secondary outcomes (11)

  1. Change in modified UCDAI at 3 weeks

    Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 3 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine

    Measured: 3 weeks

  2. Clinical and endoscopic remission rates at 6 weeks

    Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline

    Measured: 6 weeks

  3. Clinical and endoscopic remission rates at 3 weeks

    Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline

    Measured: 3 weeks

  4. Clinical improvement rate after 6 weeks

    Measured: 6 weeks

  5. Clinical improvement rate after 3 weeks

    Measured: 3 weeks

  6. Endoscopic improvement rate at 6 weeks

    Measured: 6 weeks

  7. Endoscopic improvement rate at 3 weeks

    Measured: 3 weeks

  8. Change from baseline in endoscopic appearance after 6 weeks

    Measured: 6 weeks

  9. Change from baseline in endoscopic appearance after 3 weeks

    Measured: 3 weeks

  10. Time to resolution of rectal bleeding

    Measured: Up to 6 weeks

  11. Relapse rates at 6 weeks

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionApr 2014 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586533
Sponsor's protocol ID
ZA-201
Status last verified
Jan 2014
First submitted
25 Apr 2012
Last updated
8 Jan 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zoenasa-1:4 and Mesalamine Enema in people with Ulcerative Colitis and Left-sided Ulcerative Colitis, run by Altheus Therapeutics, Inc. at 45 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 17 inclusion and 19 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 8 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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. 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?

Change in modified UCDAI at 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01586533.

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 8 Jan 2014.

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