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Table 1 Efficacy of Diclegis® compared to placebo for the treatment of NVP

From: Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy

Study Day

Statistics

PUQE score (mean ± SD) of Diclegis®-treated women

PUQE score (mean ± SD) Placebo-treated women

P-value

Baseline

 

9.0 ± 2.1

8.8 ± 2.1

 

Day 3

N

128

123

 

Day 3 PUQE score

5.9 ± 2.4

6.7 ± 2.2

 

Change from Baseline

−3.1 ± 2.7

–2.1 ± 2.4

0.002

% Change from Baseline

34.4%

23.9%

 

Day 4

N

125

120

 

Day 4 PUQE score

5.4 ± 2.2

6.3 ± 2.3

 

Change from Baseline

–3.6 ± 2.5

–2.5 ± 2.2

<0.001

% Change from Baseline

40.0%

28.4%

 

Day 5

N

122

112

 

Day 5 PUQE score

5.1 ± 2.2

5.8 ± 2.1

 

Change from Baseline

–4.0 ± 2.5

–3.0 ± 2.4

0.006

% Change from Baseline

44.4%

34.0%

 

Day 15

N

131

125

 

Day 15 PUQE score

4.2 ± 1.9

4.9 ± 2.3

 

Change from Baseline

–4.8 ± 2.7

–3.9 ± 2.6

0.006

% Change from Baseline

53.0%

44.0%

 
  1. Change in Pregnancy-Unique Quantification of Emesis score from baseline to Days 3, 4, 5 and 15