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Drug Information for ELMIRON -100 mg (pentosan polysulfate sodium) Capsules (Ortho-McNeil-Janssen Pharmaceuticals, Inc.): CLINICAL TRIALS
- CLINICAL TRIALS
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ELMIRON® was evaluated in two clinical trials for the relief of pain in patients with chronic interstitial cystitis (IC). All patients met the NIH definition of IC based upon the results of cystoscopy, cytology, and biopsy. One blinded, randomized, placebo controlled study evaluated 151 patients (145 women, 5 men, 1 unknown) with a mean age of 44 years (range 18 to 81). Approximately equal numbers of patients received either placebo or ELMIRON® 100 mg three times a day for 3 months. Clinical improvement in bladder pain was based upon the patient's own assessment. In this study, 28/74 (38%) of patients who received ELMIRON® and 13/74 (18%) of patients who received placebo, showed greater than 50% improvement in bladder pain (p=0.005).
A second clinical trial, the physician's usage study, was a prospectively designed retrospective analysis of 2499 patients who received ELMIRON® 300 mg a day without blinding. Of the 2499 patients, 2220 were women, 254 were men, and 25 were of unknown sex. The patients had a mean age of 47 years and 23% were over 60 years of age. By 3 months, 1307 (52%) of the patients had dropped out or were ineligible for analysis, overall, 1192 (48%) received ELMIRON® for 3 months; 892 (36%) received ELMIRON® for 6 months; and 598 (24%) received ELMIRON® for one year.
Patients had unblinded evaluations every 3 months for the patient's rating of overall change in pain in comparison to baseline and for the difference calculated in "pain/discomfort" scores. At baseline, pain/discomfort scores for the original 2499 patients were severe or unbearable in 60%, moderate in 33% and mild or none in 7% of patients. The extent of the patients' pain improvement is shown in Table 1.
At 3 months, 722/2499 (29%) of the patients originally in the study had pain scores that improved by one or two categories. By 6 months, in the 892 patients who continued taking ELMIRON®, an additional 116/2499 (5%) of patients had improved pain scores. After 6 months, the percent of patients who reported the first onset of pain relief was less than 1.5% of patients who originally entered in the study (see Table 2).
Table 1: Pain Scores in Reference to Baseline in Open Label Physician's Usage Study (N=2499) Trial not designed to detect onset of pain relief Efficacy Parameter 3 monthsCI = 95% confidence interval 6 months Patient Rating of Overall Change in Pain (Recollection of difference between current pain and baseline pain) 6-point scale: 1 = worse, 2 = no better, 3 = slightly improved, 4 = moderately improved, 5 = greatly improved, 6 = symptom gone N=1161Median=3Mean=3.44CI: (3.37, 3.51) N=724Median=4Mean=3.91CI: (3.83, 3.99) Change in Pain/Discomfort Score (Calculated difference in scores at the time point and baseline) 3-point scale: 1 = none or mild, 2 = moderate, 3 = severe or unbearable N=1440Median=1Mean=0.51CI: (0.45, 0.57) N=904Median=1Mean=0.66CI: (0.61, 0.71) Table 2: Number (%) of Patients with New Relief of Pain/DiscomfortFirst-time Improvement in pain/discomfort score by 1 or 2 categories in the Open-Label Physician's Usage Study (N=2499) at 3 monthsNumber (%) of patients with improvement of pain/discomfort score at 3 months when compared to baseline(n=1192) at 6 monthsNumber (%) of patients without pain/discomfort improvement at 3 months who had improvement at 6 months(n=892) Considering only the patients who continued treatment 722/1192 (61%) 116/892 (13%) Considering all the patients originally enrolled in the study 722/2499 (29%) 116/2499 (5%)
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