Clinical trial: Effect of mitemcinal (a motilin agonist) on gastric emptying in patients with gastroparesis - A randomized, multicentre, placebo-controlled study

R. W. Mccallum, O. Cynshi, S. J. Gordon, M. S. Kipnes, D. Einhorn, C. Clinkingbeard, M. M. Schuster, G. Tougas, R. S. Patel, P. B. Miner, B. M. Miskin, J. G. Moore, S. R. Weiss, S. A. Brietzke, J. K. DiBaise, D. J. Patterson, D. S. Riff, D. J. Pambianco, C. F. Barish, G. N. VerneC. A. Sninsky, R. Hardi, M. A. Safdi, R. E. Tepper, T. L. Abell, W. J. Snape, S. P. Marcuard, Thomas Nowak, C. M. Schmitt, J. A. Pino, P. Poitras, M. Olyaee, S. Sarosuh

Research output: Contribution to journalArticle

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Abstract

Background: Mitemcinal is an orally active motilin agonist that could potentially improve gastric emptying. Aim: To investigate the effect of mitemcinal on gastric emptying in patients with idiopathic and diabetic gastroparesis. Methods: In a randomized, double-blind design, 106 patients were randomized into four dosing regimens (22 to placebo and 21 each to mitemcinal 10 mg, 20 mg, 30 mg bid or 20 mg tid) for 28 days. A standardized scintigraphic gastric emptying test was performed at screening and again after completing the 4-week protocol. Results: All doses of mitemcinal showed prokinetic activity. A significant improvement in meal retention at 240 min was noted even in the lowest dose group with the greatest improvement observed with 30 mg bid group (75% vs. 10% in placebo group). Diabetic patients responded better than the idiopathic subgroup. In diabetic patients, blood glucose at 1 h after a meal showed dose-dependent elevation. Although gastroparetic symptoms improved with both mitemcinal and placebo, the prominent placebo effect was not statistically exceeded by mitemcinal. Baseline scintigraphy results exhibited no clear correlation between the severity of gastroparetic symptoms and the status of gastric emptying. Conclusion: Mitemcinal is capable of accelerating gastric emptying in both diabetic and idiopathic patients with gastroparesis.

Original languageEnglish (US)
Pages (from-to)1121-1130
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume26
Issue number8
DOIs
StatePublished - Oct 2007
Externally publishedYes

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Motilin
Gastroparesis
Gastric Emptying
Placebos
Clinical Trials
Meals
Placebo Effect
mitemcinal
Radionuclide Imaging
Blood Glucose

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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Clinical trial : Effect of mitemcinal (a motilin agonist) on gastric emptying in patients with gastroparesis - A randomized, multicentre, placebo-controlled study. / Mccallum, R. W.; Cynshi, O.; Gordon, S. J.; Kipnes, M. S.; Einhorn, D.; Clinkingbeard, C.; Schuster, M. M.; Tougas, G.; Patel, R. S.; Miner, P. B.; Miskin, B. M.; Moore, J. G.; Weiss, S. R.; Brietzke, S. A.; DiBaise, J. K.; Patterson, D. J.; Riff, D. S.; Pambianco, D. J.; Barish, C. F.; Verne, G. N.; Sninsky, C. A.; Hardi, R.; Safdi, M. A.; Tepper, R. E.; Abell, T. L.; Snape, W. J.; Marcuard, S. P.; Nowak, Thomas; Schmitt, C. M.; Pino, J. A.; Poitras, P.; Olyaee, M.; Sarosuh, S.

In: Alimentary Pharmacology and Therapeutics, Vol. 26, No. 8, 10.2007, p. 1121-1130.

Research output: Contribution to journalArticle

Mccallum, RW, Cynshi, O, Gordon, SJ, Kipnes, MS, Einhorn, D, Clinkingbeard, C, Schuster, MM, Tougas, G, Patel, RS, Miner, PB, Miskin, BM, Moore, JG, Weiss, SR, Brietzke, SA, DiBaise, JK, Patterson, DJ, Riff, DS, Pambianco, DJ, Barish, CF, Verne, GN, Sninsky, CA, Hardi, R, Safdi, MA, Tepper, RE, Abell, TL, Snape, WJ, Marcuard, SP, Nowak, T, Schmitt, CM, Pino, JA, Poitras, P, Olyaee, M & Sarosuh, S 2007, 'Clinical trial: Effect of mitemcinal (a motilin agonist) on gastric emptying in patients with gastroparesis - A randomized, multicentre, placebo-controlled study', Alimentary Pharmacology and Therapeutics, vol. 26, no. 8, pp. 1121-1130. https://doi.org/10.1111/j.1365-2036.2007.03461.x
Mccallum, R. W. ; Cynshi, O. ; Gordon, S. J. ; Kipnes, M. S. ; Einhorn, D. ; Clinkingbeard, C. ; Schuster, M. M. ; Tougas, G. ; Patel, R. S. ; Miner, P. B. ; Miskin, B. M. ; Moore, J. G. ; Weiss, S. R. ; Brietzke, S. A. ; DiBaise, J. K. ; Patterson, D. J. ; Riff, D. S. ; Pambianco, D. J. ; Barish, C. F. ; Verne, G. N. ; Sninsky, C. A. ; Hardi, R. ; Safdi, M. A. ; Tepper, R. E. ; Abell, T. L. ; Snape, W. J. ; Marcuard, S. P. ; Nowak, Thomas ; Schmitt, C. M. ; Pino, J. A. ; Poitras, P. ; Olyaee, M. ; Sarosuh, S. / Clinical trial : Effect of mitemcinal (a motilin agonist) on gastric emptying in patients with gastroparesis - A randomized, multicentre, placebo-controlled study. In: Alimentary Pharmacology and Therapeutics. 2007 ; Vol. 26, No. 8. pp. 1121-1130.
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abstract = "Background: Mitemcinal is an orally active motilin agonist that could potentially improve gastric emptying. Aim: To investigate the effect of mitemcinal on gastric emptying in patients with idiopathic and diabetic gastroparesis. Methods: In a randomized, double-blind design, 106 patients were randomized into four dosing regimens (22 to placebo and 21 each to mitemcinal 10 mg, 20 mg, 30 mg bid or 20 mg tid) for 28 days. A standardized scintigraphic gastric emptying test was performed at screening and again after completing the 4-week protocol. Results: All doses of mitemcinal showed prokinetic activity. A significant improvement in meal retention at 240 min was noted even in the lowest dose group with the greatest improvement observed with 30 mg bid group (75{\%} vs. 10{\%} in placebo group). Diabetic patients responded better than the idiopathic subgroup. In diabetic patients, blood glucose at 1 h after a meal showed dose-dependent elevation. Although gastroparetic symptoms improved with both mitemcinal and placebo, the prominent placebo effect was not statistically exceeded by mitemcinal. Baseline scintigraphy results exhibited no clear correlation between the severity of gastroparetic symptoms and the status of gastric emptying. Conclusion: Mitemcinal is capable of accelerating gastric emptying in both diabetic and idiopathic patients with gastroparesis.",
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T2 - Effect of mitemcinal (a motilin agonist) on gastric emptying in patients with gastroparesis - A randomized, multicentre, placebo-controlled study

AU - Mccallum, R. W.

AU - Cynshi, O.

AU - Gordon, S. J.

AU - Kipnes, M. S.

AU - Einhorn, D.

AU - Clinkingbeard, C.

AU - Schuster, M. M.

AU - Tougas, G.

AU - Patel, R. S.

AU - Miner, P. B.

AU - Miskin, B. M.

AU - Moore, J. G.

AU - Weiss, S. R.

AU - Brietzke, S. A.

AU - DiBaise, J. K.

AU - Patterson, D. J.

AU - Riff, D. S.

AU - Pambianco, D. J.

AU - Barish, C. F.

AU - Verne, G. N.

AU - Sninsky, C. A.

AU - Hardi, R.

AU - Safdi, M. A.

AU - Tepper, R. E.

AU - Abell, T. L.

AU - Snape, W. J.

AU - Marcuard, S. P.

AU - Nowak, Thomas

AU - Schmitt, C. M.

AU - Pino, J. A.

AU - Poitras, P.

AU - Olyaee, M.

AU - Sarosuh, S.

PY - 2007/10

Y1 - 2007/10

N2 - Background: Mitemcinal is an orally active motilin agonist that could potentially improve gastric emptying. Aim: To investigate the effect of mitemcinal on gastric emptying in patients with idiopathic and diabetic gastroparesis. Methods: In a randomized, double-blind design, 106 patients were randomized into four dosing regimens (22 to placebo and 21 each to mitemcinal 10 mg, 20 mg, 30 mg bid or 20 mg tid) for 28 days. A standardized scintigraphic gastric emptying test was performed at screening and again after completing the 4-week protocol. Results: All doses of mitemcinal showed prokinetic activity. A significant improvement in meal retention at 240 min was noted even in the lowest dose group with the greatest improvement observed with 30 mg bid group (75% vs. 10% in placebo group). Diabetic patients responded better than the idiopathic subgroup. In diabetic patients, blood glucose at 1 h after a meal showed dose-dependent elevation. Although gastroparetic symptoms improved with both mitemcinal and placebo, the prominent placebo effect was not statistically exceeded by mitemcinal. Baseline scintigraphy results exhibited no clear correlation between the severity of gastroparetic symptoms and the status of gastric emptying. Conclusion: Mitemcinal is capable of accelerating gastric emptying in both diabetic and idiopathic patients with gastroparesis.

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