# TABLE OF CONTENTS

1.  Overview

2.  Briefing Document by Hugo Gallo-Torres, M.D., Ph.D.

3.  Sample of a Written Request for Proton-Pump Inhibitors Used to Treat
    Gastroesophageal Reflux Disease

4.  Usage data for proton-pump inhibitors in pediatrics

5.  Letter from George D. Ferry, M.D.

6.  References

**List of References**

[Gastroesophageal reflux disease in pediatrics]{.underline}

1.  Faubion, WA, Zein, NN. Gastroesophageal reflux in infants and
    children. *Mayo Clinic Proc.* 1998; 73:166-173.

2.  Orenstein, SR. Management of supraesophageal complications of
    gastroesophgeal reflux disease in infants and children. *The
    American Journal of Medicine.* 2000; 108(4A):139S-143S.

3.  Vandenplas,Y, Sacr-Smits,L. Continous 24-hour esophageal pH
    monitoring in 285 asymptomatic infants 0-15 months old. *Journal of
    Pediatric Gastroenterology and Nutrition.* 1987; 6(2):220-224.

4.  Thach, BT. Reflux associated apnea in infants: Evidence for a
    laryngeal chemoreflex. *The American Journal of Medicine.* 1997;
    103(5A): 120S-124S.

### Gastroesophageal reflux in neonates

5.  Jadcherla, SR. Gastroesophageal reflux in the neonate. *Clinics in
    Perinatology*. 2002; 29(1):135-158.

6.  Newell, SJ, Booth, IW, Morgan, MEI, *et.al*. Gastro-oesophageal
    reflux in preterm infants. *Archives of Disease in Childhood*,
    1989;64:780-786.

7.  Marino, AJ, Assing, E, Carbone, MT, *et.al.* The incidence of
    gastroesophgeal reflux in preterm infants. *Journal of
    Perinatology.* 1995; 15(5):369-371.

8.  Kimball, AL, Carlton, DP. Gastroesophgeal reflux medications in the
    treatment of apnea in premature infants. *The Journal of
    Pediatrics.* 2001;138(3): 355-360.

9.  Page, M, Jeffery, H. The role of gastro-oesophgeal reflux in the
    aetiology of SIDS. *Early Human Development.* 2000; 59:127-149.

10. Barrington, KJ, Tan, K, Rich, W. Apnea at discharge and
    gastro-esophgeal reflux in the preterm infant. *Journal of
    Perinatology.* 2002; 22:8-11.

### Respiratory and supraesophageal manifestations of gastroesophageal reflux

11. Menon, AP, Schefft, GL, Thach, BT. Apnea associated with
    regurgitation in infants. *The Journal of Pediatrics.* 1985;
    106(4):625-629.

12. Orlando, R. Mechanisms of reflux-induced epithelial injuries in the
    esophagus. *The American Journal of Medicine.* 2000;
    108(4A):104S-107S.

13. Richter, JE. Gastroesophgeal reflux disease and asthma: The two are
    directly related. *The American Journal of Medicine.* 2000;
    108(4A):153S-158S.

14. Holloway, RH. Esophageal body motor response to reflux events:
    Secondary peristalsis. *The American Journal of Medicine.* 2000;
    108(4A):20S-26S.

15. Peter, CS, Sprodowski, N, Bohnhorst, B, *et.al.* Gastroesophageal
    reflux and apnea of prematurity: No temporal relationship.
    *Pediatrics.* 2002; 109(1): 8-11.

### Ethics

16. *FDA Ethics Working Group Consensus Statement on the Pediatric
    Advisory Subcommittee's November 15, 1999 Meeting.*
    ([www.fda.gov/cder/pediatric/ethics-statement.htm](http://www.fda.gov/cder/pediatric/etihics-statement.htm))
    (accessed 4/29/02).

17. *FDA Pediatric Ethics Working Group Consensus Statement on Pediatric
    Advisory Subcommittee's September 11, 2000 Meeting.*
    ([www.fda.gov/cder/pediatric/ethics-statement.htm)](http://www.fda.gov/cder/pediatric/ethics-statement.htm)).
    (accessed 4/29/02).

[Special study designs: Randomized-withdrawal trials]{.underline}

18. Temple, RJ. Special study designs: Early escape, enrichment, studies
    in non-responders. *Commun. Statist. Theory Meth.* 1994;
    23(2):499-531.

### Choice of control group in clinical studies

#### Guidance For Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials. Food and Drug Administration. May 2001.

19. Temple, R, Ellenberg, S. Placebo-controlled trials and
    active-control trials in the evaluation of new treatments. Part 1:
    Ethical and scientific issues. .*Annals of Internal Medicine*. 2000;
    133(6):455-463.

20. Ellenberg, S, Temple, R. Placebo-controlled trials and
    active-control trials in the evaluation of new treatments. Part 2:
    Practical issues and specific cases. *Annals of Interanl Medicine.*
    2000; 133(6): 464-475.

21. Temple, RJ. When are clinical trials of a given agent vs. placebo no
    longer appropriate or feasible? *Controlled Clinical Trials.* 1997;
    18:613-620

## 

## [Pharmacology of proton-pump inhibitors]{.underline}

22. James, LP. Pharmacology for the gastrointestinal tract. *Clinics in
    Perinatology.* 2002; 29(1):115-133.

23. Wolfe, MM, Sachs, G. Acid suppression: Optimizing therapy for
    gastroduodenal ulcer healing, gastroesophageal reflux disease, and
    stress-related erosive syndrome. *Gastroenterology*. 2000;
    118:S9-S31.

24. Richardson, *et.al.* Proton pump inhibitors in GI disorders.
    *Drugs*. 1998; 56(3):308-334.

25. Sachs, G, Shin, JM, Briving, C, *et.al.* The pharmacology of the
    gastric acid pump: The H^+^, K^+^ ATPase. *Annual Review of
    Pharmacology and Toxicology.* 1995; 33:277-305.