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Description
Background: Biologically derived porcine secretin has been clinically used for many years as a diagnostic agent to assess exocrine pancreas function, facilitate the cytological diagnosis of pancreatic cancer and diagnose gastrinoma. A pure synthetic porcine secretin is now available for investigational clinical use. This study compared the pharmacology of synthetically (sPS) and biologically (bPS) derived porcine secretins in normal volunteers. Methods: Secretin stimulation tests were performed in 12 healthy normal male and female volunteer subjects in a double blind, randomized, Latin square crossover design study comparing 3 doses of synthetic porcine secretin (0.05, 0.2, and 0.4 ug/Kg) with a standard dose of biologically derived porcine secretin (1 U/Kg). A double lumen tube was placed with fluoroscopic guidance into the stomach and duodenum. Baseline duodenal aspirates were collected for two 10-minute samples prior to dosing. Four aliquots were collected from 0 to 10, 10 to 20, 20 to 40, and 40 to 60 minutes after dosing. Samples were analyzed for total volume and for bicarbonate concentration. Total bicarbonate output was calculated. Results: Twelve subjects (4 males and 8 females) completed all four treatments and were analyzed. Results by treatment, volume, and bicarbonate are tabulated below. A multiple comparison test was used to compare treatment groups. The 3 escalating doses of sPS produced a linear dose response for total volume, but similar results for bicarbonate concentration from 0 to 60 minutes. The 0.2 and 0.4 ug/Kg doses of sPS were not different from the 1 U/Kg dose of bPS for volume bicarbonate concentration and total bicarbonate output from 0 to 60 minutes. Baseline adjusted bicarbonate concentration from 0 to 60 minutes was not statistically different for any treatment. Only one patient had an adverse event, which was mild, transient flushing after the 0.2 and 0.4 ug/Kg doses of sPS and after the 1 U/Kg dose of bPS. Conclusions: SPS has identical pharmacologic effects to bPS in normal subjects. For sPS, there was a near maximal stimulation of HCO3 concentration at all doses. SPS (0.2 ug/Kg) and bPS (1 U/Kg) produced statistically equivalent and almost identical results. Both drugs were safe and well tolerated. This study validates sPS as a substitute for bPS.
| Status | Finished |
|---|---|
| Effective start/end date | 10/1/97 → 9/30/99 |
Funding
- National Center for Research Resources: $293,069.00
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Projects
- 1 Finished
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GENERAL CLINICAL RESEARCH CENTER
Williams, R. R. S., Burks, A. A. W., Allen, T. B., Anderson, N. B., Sherwood, A. A., Haqq, A. A. M., Muir, A. A. J., Brown, A. A. J., Anderson, N. B., Baillie, J., Bartlett, J. A., Bell, D. Y., Blazer, D. G., Blumenthal, J. A., Bohannon, A. D., Bohannon, A. D., Bohjanen, P. R., Blazer, D. G., Brauer, L. H., Bohannon, A. D., Brown, T. D., Brown, M. T., Buckley, E. G., Buckley, R. H., Bullard, D. E., Califf, R. M., Carroll, B. J., Chen, Y. T., Clark, C. M., Clavien, P. A., Cobb, F. R., Coffey, C. E., Coffman, T. M., Cohen, H. J., Cohen, H. J., Cohen, D. P., Coleman, E. R., Cox, J. B., Cox, G. S., Crawford, J., Coleman, E. R., Cox, G. S., Cutson, T. M., Dennis, V. W., Zhelev, D. D., Drezner, M. K., Dukes-hamilton, C. S., Dunn, F. L., Drezner, M. K., Schwartz, D. D. A., Eisen, G. M., Eisenbarth, G. S., Myers, E. E. R., Feinglos, M. N., Feldman, J. M., Freemark, M. S., Frid, D. J., Friedman, N. E., Keefe, F. F. J., Gallis, H. A., Gingras, J. L., Feldman, J. M., Gockerman, J. P., Goodwin, S. D., Grant, J. P., Grigore, A. M., Guyton, J. R., Glass, P. S., Hall Iii, R. P., Hall, R. P., Grant, J. P., Hamilton, C. D., Harrell, R. M., Harville, T. O., White, H. H. K., Hall Iii, R. P., Hicks, C. B., Halperin, E. C., Hamilton, C. D., Hochmuth, R. M., Holmes, E. W., Hunt, C. M., Hurwitz, H., Iafolla, A. K., Tuttle-newhall, J. J. E., Jaffe, G., Gollob, J. J. A., Sundy, J. J. S., Johnson, M. D., Johnson, P. L., Jowell, P. S., Vieweg, J. J. W., Barroso, J. J. V., Kahler, S. G., Killenberg, P., Kishnani, P. S., Gadde, K. K. M., Langford, C. A., Williams, L. L. W., Myers, L. L. A., Johnson, P. L., Linzer, M., Livengood, C. H., Lucas, J., Lyerly, H. K., Lyles, K. W., Szczech, L. A. L. M., Macintyre, N. R., Madden, D. J., Gadde, K. K. M., Levesque, M. M. C., Mark, B., Williams, L. L. W., Markert, M. L., Mathew, R., Matzke, G. R., Mccubbin, J. A., Livengood, C. H., Lucas, J., Cahill, M. M. C., Kelley, M. M. J., Morris, M. A., Morris, M. A., Murtha, A. P., Myerson, M., Mcdonald, M. M., Telen, M. J., Mark, B., Neelon, F. A., Newman, M. F., O'Connor, C. M., Olsen, E. A., Ortel, T. L., Peters, W. P., Dahm, P. P., Phillips, G. J., Piantadosi, C. A., Pinnell, S. R., Pisetsky, D. S., Kelley, M. M. J., Morris, M. A., Polisson, R. P., Pritchett, E. L. C., Pritchett, E. L., Provenzale, D. T., Putnam, W. S., Moorman, P. P. G., Snyderman, R. R. J., Ramirez, M. J., Newman, M. F., Robertson, C. R., Rockwell, K., Roe, C. R., Rose, J. E., Roses, A. D., Piantadosi, C. A., Pinnell, S. R., Sampson, H. A., Wells, S. S. A., Sanders, D. B., Scheinman, J. I., Polisson, R. P., Schiffman, S. S., Pritchett, E. L., Schwab, S., Putnam, W. S., Seigler, H. F., Snyderman, R. R. J., Smith, S. R., Needham, D., Soper, J. T., St Clair, E. W., Steege, J. F., Sullivan, M. J., Surwit, R. S., Svetkey, L. P., Wells, S. S. A., Spratt, S. S. E., Thrailkill, K. M., Trump, D. L., Truskey, G. A. G. A., Schwab, S. J., Kraus, V. V. B., Ware, R. E., Webb, D. D., Weber, T. J., Weiner, R. D., Weinerth, J. L., Demark-wahnefried, W. W., St Clair, E. W., Wigfall, D. R., Wilfert, C. M., Anlyan, W. W. G., Williams, R. B., Williams, S. R., Williams, L. W., Wilson, J. A., Dukes, C., Federici, R., Maniatis, A. & Seldin, M.
12/1/84 → 3/31/04
Project: Research project