Clinical trial NCT01172444 (phase 3, status: terminated)
Conditions: proctitis
ICD codes: K62.7, K51.20, K51.213, K51.214, K51.211, K51.212, K51.218
Drugs: mesalamine, canasa, placebo
SMILES: NC1=CC(C(O)=O)=C(O)C=C1, NC1=CC(C(O)=O)=C(O)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    enrollment difficulties
  
Eligibility criteria:

        Inclusion Criteria:

        1. Adults, male and female, 18 to 65 years of age 2. Active, mild to moderate UP, with
        disease activity not to exceed 15 cm beyond the anal verge: the upper disease boundary will
        be confirmed by flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline
        Visit 3. Newly diagnosed or newly relapsed UP, where newly relapsed UP is defined as UP
        that has relapsed within less than and equal to 6 weeks prior to the Baseline Visit 4. A
        Disease Activity Index (DAI) score greater than or equal to 4 and less than or equal to 10
        at the Baseline Visit; the DAI must include a Physician's Global Assessment (PGA) sub-score
        of less than or equal to 2, a rectal bleeding sub-score of greater than or equal to 1 and a
        mucosal appearance sub-score of greater than or equal to 1 5. Histological confirmation of
        UP with a Histological Disease Activity Score > or equal to 1 for the biopsy taken from the
        most severe area of disease during the flexible sigmoidoscopy/colonoscopy performed within
        14 days of the Baseline Visit 6. For female patients of child-bearing potential, a negative
        serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the
        Baseline Visit; all female patients will be considered of child-bearing potential unless
        they are post-menopausal for at least one year or have been surgically sterilized
        (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) 7. Female patients of
        childbearing potential must be practicing one of the following methods of birth control and
        must agree to continue with regimen throughout the study: hormonal methods such as oral,
        implantable, injectable, or transdermal contraceptives for a minimum of one full cycle
        (based on the patient's usual menstrual cycle period) before investigational product
        administration; total abstinence from sexual intercourse (since the last menses before
        investigational product administration); intrauterine device; double barrier method
        (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream); Male
        patients must also agree to use acceptable methods of birth control with their female
        partners, and this may include use of a male condom plus spermicide. 8. Ability to give
        written informed consent 9. Ability and willingness to comply with study requirements,
        including dosing procedures, diary completion, and study visits

        Exclusion Criteria:

        1. Known history of allergic reaction or clinically significant intolerance to aspirin or
        salicylate derivatives (including mesalamine) or non-active ingredients of the
        investigational product 2. Onset of UP relapse >6 weeks prior to the Baseline Visit for
        patients experiencing a relapse of their UP (i.e., patients who are not newly diagnosed) 3.
        Severe UP as defined by a DAI score of greater than or equal to 11 or a PGA sub-score of 3
        4. Histological Disease Activity Score > or equal to 1 for the biopsy taken from the normal
        tissue above the disease margin during the flexible sigmoidoscopy/colonoscopy performed
        within 14 days of the Baseline Visit 5. UP with disease involvement greater than 15 cm
        beyond the anal verge as confirmed on flexible sigmoidoscopy/colonoscopy 6. Prior
        unsuccessful treatment of active UP or active ulcerative colitis with rectally administered
        mesalamine preparations of any strength 7. Any prior treatment of UP or ulcerative colitis
        with any oral 5-aminosalicylic acid product if used at >2 g/day, regardless of treatment
        outcome 8. Use of local, rectally administered therapies for UP or ulcerative colitis
        (e.g., suppositories or enemas containing mesalamine, etc.) within 30 days of the Baseline
        Visit 9. Use of any of the following medications: - Biological therapies (e.g., infliximab)
        within 90 days of the Baseline Visit - Immunosuppressive/immunomodulating (e.g.,
        azathioprine) medications within 90 days of the Baseline Visit - Oral, intravenous,
        intramuscular, or rectally administered corticosteroids within 30 days of the Baseline
        Visit; the use of intranasal and/or inhaled corticosteroids is permitted - Oral
        5-aminosalicylic acid products within 7 days of the Baseline Visit, if used at & less than
        or equal to 2 g/day - Oral, intravenous, or intramuscular antibiotics within 7 days of the
        Baseline Visit - Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of the
        Baseline Visit; low-dose aspirin (less than or equal to 325 mg/day) taken for
        cardio-protective reasons is permitted - Antidiarrheals, antispasmodics, and iron therapy
        within 7 days of the Baseline Visit - Transdermal nicotine products within 7 days of the
        Baseline Visit 10. A change in regimen (i.e., dosage or frequency of use) of permitted
        medications within 30 days of the Baseline Visit, or any plans to change the regimen during
        the course of this study 11. Use or treatment with an investigational drug, therapy, or
        device within 30 days of the Baseline Visit 12. A planned change in tobacco usage (e.g.,
        smoking, oral tobacco) during the study 13. Female patients who are pregnant, planning a
        pregnancy, or who are breastfeeding 14. Diseases interfering with the DAI assessment,
        including but not limited to, hemorrhoids and anal fissures 15. History of Crohn Disease,
        short bowel syndrome, or bowel surgery (except appendectomy), or active peptic ulcer 16. A
        positive stool culture for enteric pathogens (Salmonella, Shigella, Yersinia,
        Campylobacter, Vibrio, E. coli O157/H7), detection of Clostridium difficile toxin through
        immunoassay, or enteric parasites and their ova (including Giardia, Cryptosporidium, and
        Entamoeba histolytica) on routine microscopy at the Screening Visit 17. Significant
        impairment of renal or hepatic function, as defined by any of the following: - Creatinine
        >1.5 x Upper Limit Normal (ULN) - Alanine Amino Transferase (ALT) >2.5 x ULN - Aspartate
        Amino Transferase (AST) >2.5 x ULN 18. Serologic positivity for the Hepatitis B virus
        (HBV), the Hepatitis C virus (HCV), the Human Immunodeficiency Virus (HIV), or Treponema
        pallidum (the causative agent of syphilis) 19. Known history of idiopathic / chronic
        pancreatitis 20. History of active drug or alcohol abuse within the past year, or physical
        examination findings indicating the same 21. Current clinically significant urinary tract
        obstruction 22. History of coagulation disorders, including those requiring treatment with
        anticoagulant drugs (except for aspirin taken at ≤325 mg/day for cardio-protective reasons
        23. Current active malignancy or history of malignancy within the past five years, except
        for cervical carcinoma in situ, squamous or basal cell carcinoma of the skin that has been
        surgically removed, or prostate cancer that is being managed by watchful waiting
        (observation alone) 24. History of pelvic irradiation 25. Any other clinically significant
        abnormal medical condition that in the Investigators judgment would put the patient at
        increased risk of illness or injury, would interfere with study participation or would
        interfere with the evaluation or quality of the data 26. Inability or unwillingness to
        understand and comply with the requirements of the protocol for any reason, including
        dosing procedures and visit requirements 27. Previous randomization in this study