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

This study has been completed.
Sponsor:
Information provided by:
Altheus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01020708
First received: November 20, 2009
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: mesalamine
Drug: ALTH12-1:4
Drug: ALTH12-2:4
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Altheus Therapeutics, Inc.:

Primary Outcome Measures:
  • To determine the safety and tolerability of ALTH12 when given by intrarectal administration over 6 weeks to subjects with ulcerative colitis (UC) involving the left side of the colon [ Time Frame: 6 weeks treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Comparator
Mesalamine enema
Drug: mesalamine
4.0g mesalamine rectal suspension, rectally administered enema, 60ml volume, 4.0g mesalamine, once daily
Other Names:
  • Rowasa
  • mesalamine
  • 5-ASA
  • 5-aminosalicylic acid
Experimental: ALTH12-1:4
ALTH12-1:4 experimental treatment dose
Drug: ALTH12-1:4
ALTH12-1:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 1.0g N-acetylcysteine
Other Names:
  • mesalamine
  • 5-ASA
  • N-acetylcysteine
  • NAC
  • enema
Experimental: ALTH12-2:4
ALTH12-2:4 experimental treatment dose
Drug: ALTH12-2:4
ALTH12-2:4 rectal suspension, rectally administered enema, 60mL volume, 4.0g mesalamine, 2.0g N-acetylcysteine
Other Names:
  • mesalamine
  • 5-ASA
  • N-acetylcysteine
  • NAC

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020708

Locations
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Altheus Therapeutics, Inc.
Investigators
Principal Investigator: Philip B Miner, M.D. Oklahoma Foundation for Digestive Research
  More Information

No publications provided

Responsible Party: Richard F. Harty, M.D., Altheus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01020708     History of Changes
Other Study ID Numbers: ALTH12-003
Study First Received: November 20, 2009
Last Updated: March 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Altheus Therapeutics, Inc.:
colitis
inflammatory bowel disease
ulcerative colitis
rectal administration
enema
mesalamine

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Acetylcysteine
Aminosalicylic Acid
N-monoacetylcystine
Mesalamine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Antitubercular Agents
Anti-Bacterial Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on April 17, 2014