Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

NCT ID: NCT01020708

Last Updated: 2011-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-09-30

Brief Summary

This Phase I study will be a closely monitored trial of a small number of subjects to establish, preliminarily, the tolerability and safety of two ALTH12 enema formulations: ALTH12-1:4 and ALTH12-2:4. The study will be conducted in two parts. The first part will be the assessment of the safety and tolerability of a single dose of ALTH12-1:4 or the comparator, mesalamine (4.0g 5-ASA) followed by an assessment of repeated administrations of study drug (ALTH12-1:4 or comparator) for 6 weeks. The second part will be the same assessment for ALTH12-2:4. Three subjects will be enrolled in each cohort: 2 to receive ALTH12 enema therapy and 1 subject to receive comparator enema therapy. A total of up to 9 patients will be enrolled in this study, allowing for up to 3 replacement or additional patients.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Comparator

Mesalamine enema

Group Type: ACTIVE_COMPARATOR

mesalamine

Intervention Type: DRUG

4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily

ALTH12-1:4

ALTH12-1:4 experimental treatment dose

Group Type: EXPERIMENTAL

ALTH12-1:4

Intervention Type: DRUG

ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine

ALTH12-2:4

ALTH12-2:4 experimental treatment dose

Group Type: EXPERIMENTAL

ALTH12-2:4

Intervention Type: DRUG

ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine

Interventions

mesalamine

4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily

Intervention Type: DRUG

ALTH12-1:4

ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine

Intervention Type: DRUG

ALTH12-2:4

ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine

Intervention Type: DRUG

Other Intervention Names

Rowasa; 5-ASA; 5-aminosalicylic acid; mesalamine; 5-ASA; N-acetylcysteine; NAC; enema; mesalamine; 5-ASA; N-acetylcysteine; NAC

Eligibility Criteria

Inclusion Criteria

• 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 active disease or disease in remission.
• Eligible subjects will have a documented history of ulcerative colitis, and a modified UCDAI with a sigmoidoscopy score of 1 point or less and Physician's rating of disease score of 1 point or less (mild or remission).
• Laboratory data:

1. White blood cell count between 4,500 and 10,000 cells/mL

2. Platelet count: 150,000-450,000 cells/mL

3. Hemoglobin > 10.0 g/dL

4. Total bilirubin < 1.5 mg/dL

5. Aspartate aminotransferase < 100 u/dL

6. Alanine aminotransferase < 100 u/dL

7. Alkaline phosphatase < 250 u/dL

8. Blood urine nitrogen < 40 mg/dL

9. Creatinine < 1.5 mg/dL

10. Amylase < 150 U/L

• Satisfied one of the following:
• Female subjects of childbearing potential must have a negative serum 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.

Exclusion Criteria

Subjects will be excluded if:

• They have documented history of 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 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
• They have shown evidence of high grade dysplasia on endoscopic examinations.
• Their stool contains enteric pathogens or Clostridium difficile toxins.
• They have a history of recurrent Clostridium difficile infection.
• They have prior history of biologic therapy.
• They have received systemic steroids or immunosuppressants within the previous 4 weeks.
• Treatment in the last 2 weeks that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) and/or 5-ASA enema (e.g. Rowasa®).
• 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 abuse.
• They have a known allergy to N-acetylcysteine or Mesalamine.
• 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.
• Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Altheus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Altheus Therapeutics, Inc.

Principal Investigators

Philip B Miner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Foundation for Digestive Research

Locations

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

ALTH12-003

Identifier Type: -

Identifier Source: org_study_id