What is the difference between pentasa and asacol

Treatment assignments were balanced according to the inflamed areas proctitis-type or others and the severity of the disease range of UC-DAI at initial assessment: 3—5 or 6—8 with the use of a biased-coin minimization algorithm.

Balance within each medical center was also taken into consideration. A person independent from the study was in charge of the random allocation. Seven patients were assigned as a block as follows: 2 to a group given the pH-dependent release formulation at 2.

The randomization code was sealed and stored until the blind was removed. At the time of informed consent, investigators evaluated the background characteristics of patients. After an observation period of 3—14 days from the time of informed consent, investigators assessed patients for their eligibility for enrolment according to criteria previously described.

At the time of the eligibility assessment the UC-DAI was calculated using a previously reported method. Each score was based on the patients' diary for the last three days. The area of the inflammation was also determined by colonoscopy. Patients who were judged as eligible were enrolled and assigned to investigational drugs by a central registration center, and then administration was started.

The investigational drugs were administered three times daily for eight weeks. During the study, each patient recorded the condition of their bloody stools, stool frequency and drug compliance in their diary and visited the medical center every two weeks.

Colonoscopy was performed at eight weeks or at withdrawal from the study, and UC-DAI was calculated at that time. To evaluate safety, clinical laboratory data and vital signs were checked at the time of informed consent and four weeks and eight weeks after enrolment or upon withdrawal. The presence or absence of adverse events AEs and adverse drug reactions ADRs were recorded by investigators at each visit. In the statistical analysis, the primary endpoint was the decrease in UC-DAI at the final assessment.

The principal aim of this study was to demonstrate two hypotheses with closed procedure; the first was the superiority of pH In the primary endpoint, a closed procedure was adopted. Individual hypotheses were verified by the following methods: 1 verification of the superiority of pH The secondary endpoints were the proportion of remission and the proportion of efficacy. Remission was defined as patients with a UC-DAI of 2 or less and a bloody stool score of 0 at the final assessment.

Efficacy was defined as remission or improvement. Improvement was defined as patients with the decrease in UC-DAI by two points or more, except patients who experienced a remission. Multiplicity of these analyses was not taken into consideration. The statistical analyses were conducted by ZERIA Pharmaceutical, Japan, based on statistical advice of an expert independent of this study.

The number of patients required to demonstrate the superiority of pH The number of the patients required to demonstrate the noninferiority of pH According to the above estimations, we decided to enroll at least 60 patients in each active-drug group considering the patients excluded from the analysis set.

Placebo was used as the reference in the analysis for efficacy, and the number of patients in the placebo group was half of that in each of the active drug groups. The full analysis set FAS consisted of all participants except those who had not taken even one tablet of the investigational drugs, those who did not comply with Good Clinical Practice GCP , those who met exclusion criteria 1 and those whose data were missing.

Concerning the withdrawal cases, their adoption was to be decided before the blind was removed. The statistical analysis of efficacy was performed primarily based on data from the FAS followed by comparison with those from the PPS. The dataset for safety consisted of all participants except those who had not taken even one tablet of the investigational drug and those who did not comply with the GCP.

We established an image assessment committee independent from the investigators to ensure the reliability of the mucosal appearance scores, and each of the three members of the committee blindly and independently scored mucosal appearance by examining photos provided by the investigators.

When the scores obtained from all three members was the same, that score was regarded as a judgment by the committee. If the scores were different, the committe members discussed the case until they reached a consensus.

When the judgment by the committee and the evaluation by the investigators were the same, it was defined as an agreement case. Investigators obtained informed consent from patients during the period from November to July and completed the final follow-up in September Fig. Of the patients, patients were assigned to all the groups pH All patients took the investigational drugs at least once. A total of 47 patients pH The most frequent reason for withdrawal was aggravation of UC pH There were patients in the FAS pH Therefore, the results analyzed according to the FAS will be shown at the following.

The difference between pH The secondary endpoints, specifically the proportions of the remission and efficacy, were the highest in pH The data of 13 patients pH Proportion of remission and efficacy.

Each graph includes patients for analyses pH A: The proportion of patients who experienced a remission was There were statistically significant differences from Placebo in all active-drug groups.

B: Efficacy was archived in There were significant differences from Placebo in both pH Among the patients with proctitis-type UC, there were significant differences both in pH The proportion was In all the disagreement cases there was one degree of difference in the scores between the judges by the committee and the evaluations by the investigators.

These tend to be minor. Rarely, mesalamine can cause problems with your blood. You should tell your physician immediately if you have any unexplained bleeding, bruising, red or purple discolorations of the skin, sore throat or a high temperature fever , or if you feel generally unwell. Ulcerative colitis causes inflammation of the intestine, which leads to problems such as ulceration and bleeding. This causes symptoms such as abdominal pain and diarrhea. Crohn's disease is a condition which causes inflammation of any part of the gastrointestinal system.

When the inflammation is in the area where the small intestine joins the large intestine then it is called Crohn's ileo-colitis. Aminosalicylates are a group of medicines commonly used to treat inflammatory bowel diseases such as these. Mesalamine is one of the most commonly used aminosalicylates. Although it is not clear exactly how mesalamine works, it is thought to act on cells lining the intestine to change the way these cells make and release certain chemicals.

These chemicals are thought to be a factor in causing the symptoms of ulcerative colitis. Mesalamine allows the damaged intestine to recover and helps to prevent symptoms from flaring up again. There are a number of different mesalamine preparations, strengths and brands. The way the manufacturers make each of these brands differs slightly; this allows the different brands to release mesalamine in specific areas of the intestine. You will be prescribed the brand that allows mesalamine to be released in the part of your intestine which requires it most.

Mesalamine can be taken by mouth as capsules or tablets, or it can be given into the back passage as a suppository or enema. Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking mesalamine it is important that your physician knows:. Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them.

The table below contains some of the most common ones associated with mesalamine. The scheme below demonstrates the areas of 5-ASA action depending on the form of the drug being used:.

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