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Table 3 Summary of efficacy at end of double-blind treatment (ITT Data Set)

From: Fulranumab in patients with interstitial cystitis/bladder pain syndrome: observations from a randomized, double-blind, placebo-controlled study

 

Placebo

(N = 17)

Fulranumab 9 mg

(N = 14)

Primary Endpoint – Average Pain Intensity Scorea

  

 Baseline, mean ± SD

6.8 ± 1.30

6.1 ± 1.11

 Change at end of double-blind treatment period, mean ± SD

−1.2 ± 1.88

−1.4 ± 1.41

 Difference of means (95% CI)

 

−0.2 ± 0.64 (−1.52, 1.10)

% Responders defined as:

  

  ≥ 30% improvement in average pain intensity scorea

5 (33.3%)

4 (30.8%)

  ≥ 50% improvement in average pain intensity scorea

3 (20.0%)

3 (23.1%)

Secondary Endpoint – Worst Pain Intensity Scorea

  

 Baseline, mean ± SD

7.6 ± 1.32

6.9 ± 1.13

 Change at end of double-blind treatment period, mean ± SD

−1.5 ± 1.90

−1.5 ± 1.55

 Difference of means (95% CI)

 

−0.1 ± 0.66 (−1.44, 1.28)

Other Secondary Endpoints:

  

 ICSI Total Scoreb

  

  Baseline, mean ± SD

16.5 ± 2.92

14.6 ± 3.27

  Change at end of double-blind treatment period, mean ± SD

−3.0 ± 3.97

−4.4 ± 4.40

  Difference of means (95% CI)

 

−1.4 ± 1.50 (−4.50, 1.65)

 PUF Total Scorec

  

  Baseline, mean ± SD

26.2 ± 6.86

24.3 ± 4.89

  Change at end of double-blind treatment period, mean ± SD

−4.2 ± 5.38

−6.1 ± 5.16

  Difference of means (95% CI)

 

−1.9 ± 1.91 (−5.81, 1.99)

 PPBC Scored

  

  Baseline, mean ± SD

4.9 ± 0.86

4.7 ± 0.61

  Change at end of double-blind treatment period, mean ± SD

−0.5 ± 1.12

−0.9 ± 1.23

  Difference of means (95% CI)

 

−0.3 ± 0.42 (−1.19, 0.54)

 Daytime urinary frequencye

  

  Baseline, mean ± SD

16.5 ± 11.66

11.0 ± 6.68

  Change at end of double-blind treatment period, mean ± SD

0.8 ± 3.92

0.5 ± 2.95

  Difference of means (95% CI)

 

−0.3 ± 1.33 (−3.02, 2.44)

 Nocturnal urinary frequencye

  

  Baseline, mean ± SD

5.0 ± 4.36

3.8 ± 3.28

  Change at end of double-blind treatment period, mean ± SD

0.6 ± 5.33

−0.4 ± 1.33

  Difference of means (95% CI)

 

−1.0 ± 1.52 (−4.16, 2.09)

  1. ICSI O’Leary-Sant Interstitial Cystitis Symptoms Index, PPBC Patient Perception of Bladder Condition, PUF Pelvic Pain and Urgency/Frequency Questionnaire
  2. aAn 11-point scale, ranging from 0 (“no pain”) to 10 (“pain as bad as you can imagine”)
  3. bSum of 4 individual question ratings, each on a 0 to 5 scale, where higher scores indicate worse symptoms
  4. cA 12-item scale, with total score (sum of the symptom and bother subscale scores) ranging for 0 to 35; higher scores indicate worse symptoms
  5. dSingle item global measure of bladder condition rated on a 6-point scale
  6. eDerived as an average number of events over the 7 consecutive days prior to each visit
  7. Mean of all non-missing scores after first dose and up to last non-missing score for the 12-week double-blind period
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BMC Urology

ISSN: 1471-2490

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