Some Favorite Datasets from Early Phases of Drug Research

Dose Response/Selection Study in GERD Patients

Part 1 - Table 3

Twelve Gastroesophageal Reflux Disease (GERD) patients were allocated randomly to one of four treatment sequences of 0 (placebo), 10, 20, and 40 mg a.m. of a drug in a four period crossover design. On the fifth (last) day of each treatment period and the study baseline period, percent reflux time (% RT), the number of reflux episodes per hour (# EPS/HR), and the number of reflux episodes greater than five minutes in a 12 hour period (#EPS > 5'/12 HR) were recorded for each patient using ambulatory 24-hour esophageal pH monitoring. Measurements were taken while the patient was in the upright (U) or supine (S) positions. The time (hours) in the upright and supine positions was recorded. A seven day washout period separated the treatment periods.

The data recorded in the upright and supine positions are shown in Table 3. Typically, these data are reported separately and combined in a 24 hour evaluation on which a medical decision is made.

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Part 1 - Table 3
Dose Response/Selection Study in GERD Patients
________________________________Patient______________________________
Variable Dose Pos 1 2 3 4 5 6 7 8 9 10 11 12
% RT Pre U 21.53 11.02 11.92 10.76 56.58 4.54 6.67 10.86 22.03 19.53 13.42 11.04
S 36.94 31.34 0.74 5.93 63.22 12.26 22.59 4.71 0.00 18.86 3.03 4.58
0 U 9.44 20.67 16.34 9.50 19.58 17.05 8.86 4.78 9.27 19.25 16.16 27.70
S 6.55 35.45 47.84 7.77 15.17 26.09 43.33 0.00 12.05 5.21 8.12 1.86
10 U 0.53 3.52 18.50 9.23 10.89 1.59 4.78 11.14 1.71 8.17 2.05 7.62
S 1.01 23.33 1.63 1.34 47.33 1.24 12.71 0.16 0.00 19.26 1.94 3.92
20 U 2.18 0.31 0.36 1.03 21.78 0.00 1.31 0.30 1.33 1.12 1.11 2.30
S 11.58 0.00 0.62 0.00 21.89 0.00 9.44 0.00 0.00 8.50 0.00 5.51
40 U 3.27 0.00 1.05 0.41 0.73 0.00 0.13 0.37 0.60 0.99 1.36 0.78
S 28.39 3.57 0.35 0.00 1.29 0.00 1.84 0.00 0.00 0.00 15.19 0.00
#EPS/HR Pre U 18.67 9.82 4.94 11.19 23.75 1.75 8.20 13.23 6.34 8.44 7.08 16.44
S 9.42 16.33 1.11 1.68 10.17 1.40 5.67 1.65 0.00 2.75 0.81 1.88
0 U 11.66 11.23 13.48 9.94 15.94 5.70 8.06 4.56 6.33 7.98 7.26 22.34
S 4.89 15.05 3.53 3.07 10.34 1.57 18.15 0.29 2.41 1.98 3.03 1.92
10 U 1.08 1.66 11.68 8.59 8.32 0.51 4.84 5.93 3.14 6.39 2.03 6.14
S 0.36 4.15 1.86 1.01 9.73 0.50 3.19 0.19 0.12 4.16 0.77 1.82
20 U 3.34 0.18 0.50 1.99 14.10 0.00 2.47 1.21 0.74 2.01 3.03 5.25
S 2.74 0.00 0.37 0.00 12.07 0.00 2.12 0.00 0.00 1.59 0.10 2.05
40 U 2.81 0.00 1.68 1.22 1.76 0.00 0.30 1.02 0.66 1.92 2.64 2.88
S 8.52 0.63 0.53 0.13 1.93 0.00 1.00 0.10 0.00 0.00 1.68 0.00
#EPS > Pre U 2.00 0.77 4.01 0.00 11.05 2.33 0.00 0.00 5.85 3.35 2.58 0.75
5'/12HR S 11.00 10.39 0.00 2.25 26.78 2.80 8.00 1.41 0.00 11.87 2.42 1.50
0 U 0.98 6.61 4.65 0.88 5.03 5.95 2.06 0.88 2.78 5.04 5.98 4.97
S 0.00 7.85 11.29 4.76 4.97 7.83 7.38 0.00 3.04 1.25 4.03 0.74
10 U 0.00 1.37 2.61 0.85 3.70 0.77 0.00 3.60 0.00 2.56 0.00 3.28
S 0.00 11.08 0.00 0.00 12.80 1.49 3.74 0.00 0.00 9.73 0.00 1.28
20 U 0.00 0.00 0.00 0.00 6.53 0.00 0.00 0.00 0.68 0.00 0.00 0.00
S 3.52 0.00 0.00 0.00 8.52 0.00 2.46 0.00 0.00 2.01 0.00 4.11
40 U 1.27 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
S 11.61 0.95 0.00 0.00 0.00 0.00 1.10 0.00 0.00 0.00 3.36 0.00
Hours Pre U 12.00 15.58 14.97 13.32 15.20 15.43 15.00 15.50 16.42 14.33 18.63 16.00
S 12.00 8.08 9.03 10.68 8.07 8.57 9.00 8.50 7.58 9.10 4.95 8.00
0 U 12.18 14.52 15.50 13.68 11.92 16.13 17.50 13.60 12.95 14.28 18.05 14.50
S 11.45 9.17 8.50 10.08 12.08 7.67 6.50 10.40 7.88 9.60 5.95 16.17
10 U 15.70 17.50 13.78 14.08 16.22 15.68 11.15 13.32 15.62 14.08 18.72 14.65
S 8.25 6.50 10.22 9.92 7.50 8.05 12.85 10.32 8.35 9.87 5.17 9.35
20 U 13.78 16.23 14.07 14.55 18.37 16.53 8.90 16.57 17.55 11.95 13.53 15.23
S 10.22 7.75 8.02 9.13 5.63 7.18 14.65 7.43 6.45 11.97 10.47 8.77
40 U 18.83 11.38 14.27 16.45 13.65 16.73 13.12 13.67 16.65 15.12 15.88 14.93
5.17 12.62 9.45 7.55 10.35 7.22 10.88 10.33 7.35 8.87 7.13 8.95

Dose Sequence
------------>Patients
40,  0, 10, 201, 3,  9
20, 10,  0, 402, 4, 10
10, 20, 40,  05, 8, 11
 0, 40, 20, 106, 7, 12

Source:

Bradstreet, T.E. (1991) "Some Favorite Data Sets from Early Phases of Drug Research." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 14, 1997 - THS