CTRI/2010/091/000237已完成3 期
A multicentric, prospective, double-blind, randomized, parallel group study to compare the efficacy, tolerability and safety of Mesalamine, 800 mg (Zydus, CHL) Versus Asacol® HD (mesalamine) delayed release tablets 800 mg (Procter & Gamble Pharmaceuticals) and placebo in the treatment of moderately active Ulcerative Colitis. - MESO.09.001.01.1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Subjects must provide the written informed consent prior to any study related activity/procedure being performed.
- •2. Subjects must be 18 years of age or older with no known medical conditions that, in the investigator?s opinion, may interfere with study participation.
- •3. Newly diagnosed or relapsing (relapsed ≤ 6 weeks prior to randomisation) active UC (score of 4?10 on a modified UC?DAI score). Diagnosis and scoring shall be based on the results of sigmoidoscopy/colonoscopy and biopsy, which shall be done within 2 weeks prior to randomization, and recall of symptoms of rectal bleeding and stool frequency of last 3 days before screening of the subjects.
- •4. Inflammation extending 15 cm beyond the anal verge confirmed by sigmoidoscopy or colonoscopy.
- •5. The sigmoidoscopy / colonoscopy score should be ≥ 1 for inclusion of subject. In case, on sigmoidoscopy, if the disease is not limited to 30 cm from anal verge and upper margin is not visible, then a colonoscopy shall be done.
- •6. Physician?s Global Assessment (PGA) score of 2.
- •7. Subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.
排除标准
- •1. Subject is contraindicated to the use of 5-ASA or having known or suspected allergy to 5-ASA or salicylic acid (i.e. aspirin).
- •2. Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose 2.4g/day for induction of remission within the previous year.
- •3. Previously failed to respond to steroids within the previous year.
- •4. Current relapse lasting more than 6 weeks prior to randomization.
- •5. Crohn?s disease, any active peptic ulcer disease, bleeding disorders, short bowel syndrome or history of bowel surgery in the past, except appendectomy.
- •6. Isolated proctitis, extent of inflammation being ≤ 15 cm from the anal verge.
- •7. In the opinion of investigator if subject has immediate or significant risk of toxic megacolon.
- •8. Impaired renal function (creatinine 1.2 mg %) or impaired hepatic function (AST/ALT 2 times UNL).
- •9. Subjects known to be HBsAg or Hepatitis C antibody positive.
- •10. Severe UC defined by the following criteria:6 bloody stools daily with one or more of the following:
- •a) Oral temperature 37.8°C
- •b) Pulse rate 90/min
- •c) Hemoglobin 10 g/dL
- •11. Stools showing positive culture for enteric pathogens (Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter) or those with Clostridium difficile toxin present or with ova or parasites as detected by microscopy.
- •12. The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
- •a) Loperamide and other antidiarrheal agents, mucilages, antibiotics: 1 week wash-out.
- •b) Oral or rectal steroids: 4 weeks wash-out.
- •c) Repeated treatment ( 3days of use) of non steroidal anti-inflammatory drugs (NSAID) oral or rectal route: 1 week wash-out (aspirin ≤ 325 mg/day used for cardioprotection is allowed).
- •d) Sulfasalazine 2.4g/day or mesalazine or 4-ASA at a higher dose than what is permitted in the local formulary or standard care for maintenance treatment: 4 weeks wash-out
- •e) Immunomodulating/suppressing drugs: 6 weeks wash out.
- •f) Probiotics: 1 Week
- •13. Pregnant, nursing mothers or any subject planning a pregnancy within the next 2 months or judged to be using inadequate contraceptive measures (adequate contraceptive measures include: sterilisation, Intrauterine device [IUD], oral contraceptives or double barrier methods).
- •14. Participation in another clinical trial or having taken an experimental drug within last 30 days prior to the study entry.
- •15. Previous participation in this trial.
- •16. Known or suspected abuse of illicit drugs and /or alcohol.
- •17. Unwilling or unable to comply with the protocol requirements.
研究者
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