Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: A randomized, multi-center, placebo-controlled trial

R. W. McCallum, O. Cynshi, T. Abell, R. Albery, K. Amin, C. Arauz-Pacheco, D. Arkin, G. August, C. J. Baumgartner, B. Bleau, B. Bode, L. Bonner, S. Brady, D. Buth, R. Chasen, R. Cherlin, M. Conway, P. Dandona, J. DiBaise, B. DolinA. Firek, R. Gaona, S. Garg, S. Gebhart, D. Geenen, G. Gerety, B. J. Goldstein, R. Graf, R. Hardi, L. Harstine, B. Hoffman, R. Hogan, J. Hone, A. K. Jain, M. Mazen Jamal, J. Johanson, S. Karne, M. Kipnes, E. LaCava, G. Ledger, H. Lilienfeld, J. Liljenquist, L. Loman, G. Lopez, A. Malik, I. Marcadis, S. Mayeda, M. Meredith, J. Mersey, C. Monder, J. Morelli, E. Morris, N. Murali, B. Neustater, M. Olyaee, C. Owyang, C. Page, H. Parkman, R. Peterson, S. Plevin, J. Popp, E. Portnoy, C. Raine, R. A. Ramanujan, J. Reed, D. Riff, M. Rodriguez, R. Rood, M. Rosenberg, M. Safdi, I. Sarosiek, C. Schmitt, M. Shepherd, T. W. Sherraden, H. J. Simon, B. Sindler, D. Stanton, E. Stephens, M. Stern, L. Stonesifer, D. Sutton, M. Swaim, S. Swami, O. Tatpati, A. Thannoun, T. Tobey, P. Tung, G. B. Waldon, R. Weinstein, P. Weissman, P. Winkle, J. Witte, J. Wo, J. Wolosin, F. Zieve

Research output: Contribution to journalArticle

75 Citations (Scopus)

Abstract

Background: Mitemcinal, an oral motilin agonist, accelerates gastric emptying. Aim: To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. Methods: In a randomized, double-blind design, 392 insulin-requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period. Results: Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels. Conclusions: Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.

Original languageEnglish (US)
Pages (from-to)107-116
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume26
Issue number1
DOIs
StatePublished - Jul 1 2007

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Motilin
Gastroparesis
Placebos
Gastric Emptying
mitemcinal
Hemoglobins
Body Mass Index
Clinical Trials
Insulin
Therapeutics

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

Cite this

Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy : A randomized, multi-center, placebo-controlled trial. / McCallum, R. W.; Cynshi, O.; Abell, T.; Albery, R.; Amin, K.; Arauz-Pacheco, C.; Arkin, D.; August, G.; Baumgartner, C. J.; Bleau, B.; Bode, B.; Bonner, L.; Brady, S.; Buth, D.; Chasen, R.; Cherlin, R.; Conway, M.; Dandona, P.; DiBaise, J.; Dolin, B.; Firek, A.; Gaona, R.; Garg, S.; Gebhart, S.; Geenen, D.; Gerety, G.; Goldstein, B. J.; Graf, R.; Hardi, R.; Harstine, L.; Hoffman, B.; Hogan, R.; Hone, J.; Jain, A. K.; Mazen Jamal, M.; Johanson, J.; Karne, S.; Kipnes, M.; LaCava, E.; Ledger, G.; Lilienfeld, H.; Liljenquist, J.; Loman, L.; Lopez, G.; Malik, A.; Marcadis, I.; Mayeda, S.; Meredith, M.; Mersey, J.; Monder, C.; Morelli, J.; Morris, E.; Murali, N.; Neustater, B.; Olyaee, M.; Owyang, C.; Page, C.; Parkman, H.; Peterson, R.; Plevin, S.; Popp, J.; Portnoy, E.; Raine, C.; Ramanujan, R. A.; Reed, J.; Riff, D.; Rodriguez, M.; Rood, R.; Rosenberg, M.; Safdi, M.; Sarosiek, I.; Schmitt, C.; Shepherd, M.; Sherraden, T. W.; Simon, H. J.; Sindler, B.; Stanton, D.; Stephens, E.; Stern, M.; Stonesifer, L.; Sutton, D.; Swaim, M.; Swami, S.; Tatpati, O.; Thannoun, A.; Tobey, T.; Tung, P.; Waldon, G. B.; Weinstein, R.; Weissman, P.; Winkle, P.; Witte, J.; Wo, J.; Wolosin, J.; Zieve, F.

In: Alimentary Pharmacology and Therapeutics, Vol. 26, No. 1, 01.07.2007, p. 107-116.

Research output: Contribution to journalArticle

McCallum, RW, Cynshi, O, Abell, T, Albery, R, Amin, K, Arauz-Pacheco, C, Arkin, D, August, G, Baumgartner, CJ, Bleau, B, Bode, B, Bonner, L, Brady, S, Buth, D, Chasen, R, Cherlin, R, Conway, M, Dandona, P, DiBaise, J, Dolin, B, Firek, A, Gaona, R, Garg, S, Gebhart, S, Geenen, D, Gerety, G, Goldstein, BJ, Graf, R, Hardi, R, Harstine, L, Hoffman, B, Hogan, R, Hone, J, Jain, AK, Mazen Jamal, M, Johanson, J, Karne, S, Kipnes, M, LaCava, E, Ledger, G, Lilienfeld, H, Liljenquist, J, Loman, L, Lopez, G, Malik, A, Marcadis, I, Mayeda, S, Meredith, M, Mersey, J, Monder, C, Morelli, J, Morris, E, Murali, N, Neustater, B, Olyaee, M, Owyang, C, Page, C, Parkman, H, Peterson, R, Plevin, S, Popp, J, Portnoy, E, Raine, C, Ramanujan, RA, Reed, J, Riff, D, Rodriguez, M, Rood, R, Rosenberg, M, Safdi, M, Sarosiek, I, Schmitt, C, Shepherd, M, Sherraden, TW, Simon, HJ, Sindler, B, Stanton, D, Stephens, E, Stern, M, Stonesifer, L, Sutton, D, Swaim, M, Swami, S, Tatpati, O, Thannoun, A, Tobey, T, Tung, P, Waldon, GB, Weinstein, R, Weissman, P, Winkle, P, Witte, J, Wo, J, Wolosin, J & Zieve, F 2007, 'Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: A randomized, multi-center, placebo-controlled trial', Alimentary Pharmacology and Therapeutics, vol. 26, no. 1, pp. 107-116. https://doi.org/10.1111/j.1365-2036.2007.03346.x
McCallum, R. W. ; Cynshi, O. ; Abell, T. ; Albery, R. ; Amin, K. ; Arauz-Pacheco, C. ; Arkin, D. ; August, G. ; Baumgartner, C. J. ; Bleau, B. ; Bode, B. ; Bonner, L. ; Brady, S. ; Buth, D. ; Chasen, R. ; Cherlin, R. ; Conway, M. ; Dandona, P. ; DiBaise, J. ; Dolin, B. ; Firek, A. ; Gaona, R. ; Garg, S. ; Gebhart, S. ; Geenen, D. ; Gerety, G. ; Goldstein, B. J. ; Graf, R. ; Hardi, R. ; Harstine, L. ; Hoffman, B. ; Hogan, R. ; Hone, J. ; Jain, A. K. ; Mazen Jamal, M. ; Johanson, J. ; Karne, S. ; Kipnes, M. ; LaCava, E. ; Ledger, G. ; Lilienfeld, H. ; Liljenquist, J. ; Loman, L. ; Lopez, G. ; Malik, A. ; Marcadis, I. ; Mayeda, S. ; Meredith, M. ; Mersey, J. ; Monder, C. ; Morelli, J. ; Morris, E. ; Murali, N. ; Neustater, B. ; Olyaee, M. ; Owyang, C. ; Page, C. ; Parkman, H. ; Peterson, R. ; Plevin, S. ; Popp, J. ; Portnoy, E. ; Raine, C. ; Ramanujan, R. A. ; Reed, J. ; Riff, D. ; Rodriguez, M. ; Rood, R. ; Rosenberg, M. ; Safdi, M. ; Sarosiek, I. ; Schmitt, C. ; Shepherd, M. ; Sherraden, T. W. ; Simon, H. J. ; Sindler, B. ; Stanton, D. ; Stephens, E. ; Stern, M. ; Stonesifer, L. ; Sutton, D. ; Swaim, M. ; Swami, S. ; Tatpati, O. ; Thannoun, A. ; Tobey, T. ; Tung, P. ; Waldon, G. B. ; Weinstein, R. ; Weissman, P. ; Winkle, P. ; Witte, J. ; Wo, J. ; Wolosin, J. ; Zieve, F. / Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy : A randomized, multi-center, placebo-controlled trial. In: Alimentary Pharmacology and Therapeutics. 2007 ; Vol. 26, No. 1. pp. 107-116.
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title = "Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy: A randomized, multi-center, placebo-controlled trial",
abstract = "Background: Mitemcinal, an oral motilin agonist, accelerates gastric emptying. Aim: To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. Methods: In a randomized, double-blind design, 392 insulin-requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50{\%} of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75{\%} positive weekly responses for the whole treatment period. Results: Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6{\%} increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10{\%}) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels. Conclusions: Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.",
author = "McCallum, {R. W.} and O. Cynshi and T. Abell and R. Albery and K. Amin and C. Arauz-Pacheco and D. Arkin and G. August and Baumgartner, {C. J.} and B. Bleau and B. Bode and L. Bonner and S. Brady and D. Buth and R. Chasen and R. Cherlin and M. Conway and P. Dandona and J. DiBaise and B. Dolin and A. Firek and R. Gaona and S. Garg and S. Gebhart and D. Geenen and G. Gerety and Goldstein, {B. J.} and R. Graf and R. Hardi and L. Harstine and B. Hoffman and R. Hogan and J. Hone and Jain, {A. K.} and {Mazen Jamal}, M. and J. Johanson and S. Karne and M. Kipnes and E. LaCava and G. Ledger and H. Lilienfeld and J. Liljenquist and L. Loman and G. Lopez and A. Malik and I. Marcadis and S. Mayeda and M. Meredith and J. Mersey and C. Monder and J. Morelli and E. Morris and N. Murali and B. Neustater and M. Olyaee and C. Owyang and C. Page and H. Parkman and R. Peterson and S. Plevin and J. Popp and E. Portnoy and C. Raine and Ramanujan, {R. A.} and J. Reed and D. Riff and M. Rodriguez and R. Rood and M. Rosenberg and M. Safdi and I. Sarosiek and C. Schmitt and M. Shepherd and Sherraden, {T. W.} and Simon, {H. J.} and B. Sindler and D. Stanton and E. Stephens and M. Stern and L. Stonesifer and D. Sutton and M. Swaim and S. Swami and O. Tatpati and A. Thannoun and T. Tobey and P. Tung and Waldon, {G. B.} and R. Weinstein and P. Weissman and P. Winkle and J. Witte and J. Wo and J. Wolosin and F. Zieve",
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TY - JOUR

T1 - Efficacy of mitemcinal, a motilin agonist, on gastrointestinal symptoms in patients with symptoms suggesting diabetic gastropathy

T2 - A randomized, multi-center, placebo-controlled trial

AU - McCallum, R. W.

AU - Cynshi, O.

AU - Abell, T.

AU - Albery, R.

AU - Amin, K.

AU - Arauz-Pacheco, C.

AU - Arkin, D.

AU - August, G.

AU - Baumgartner, C. J.

AU - Bleau, B.

AU - Bode, B.

AU - Bonner, L.

AU - Brady, S.

AU - Buth, D.

AU - Chasen, R.

AU - Cherlin, R.

AU - Conway, M.

AU - Dandona, P.

AU - DiBaise, J.

AU - Dolin, B.

AU - Firek, A.

AU - Gaona, R.

AU - Garg, S.

AU - Gebhart, S.

AU - Geenen, D.

AU - Gerety, G.

AU - Goldstein, B. J.

AU - Graf, R.

AU - Hardi, R.

AU - Harstine, L.

AU - Hoffman, B.

AU - Hogan, R.

AU - Hone, J.

AU - Jain, A. K.

AU - Mazen Jamal, M.

AU - Johanson, J.

AU - Karne, S.

AU - Kipnes, M.

AU - LaCava, E.

AU - Ledger, G.

AU - Lilienfeld, H.

AU - Liljenquist, J.

AU - Loman, L.

AU - Lopez, G.

AU - Malik, A.

AU - Marcadis, I.

AU - Mayeda, S.

AU - Meredith, M.

AU - Mersey, J.

AU - Monder, C.

AU - Morelli, J.

AU - Morris, E.

AU - Murali, N.

AU - Neustater, B.

AU - Olyaee, M.

AU - Owyang, C.

AU - Page, C.

AU - Parkman, H.

AU - Peterson, R.

AU - Plevin, S.

AU - Popp, J.

AU - Portnoy, E.

AU - Raine, C.

AU - Ramanujan, R. A.

AU - Reed, J.

AU - Riff, D.

AU - Rodriguez, M.

AU - Rood, R.

AU - Rosenberg, M.

AU - Safdi, M.

AU - Sarosiek, I.

AU - Schmitt, C.

AU - Shepherd, M.

AU - Sherraden, T. W.

AU - Simon, H. J.

AU - Sindler, B.

AU - Stanton, D.

AU - Stephens, E.

AU - Stern, M.

AU - Stonesifer, L.

AU - Sutton, D.

AU - Swaim, M.

AU - Swami, S.

AU - Tatpati, O.

AU - Thannoun, A.

AU - Tobey, T.

AU - Tung, P.

AU - Waldon, G. B.

AU - Weinstein, R.

AU - Weissman, P.

AU - Winkle, P.

AU - Witte, J.

AU - Wo, J.

AU - Wolosin, J.

AU - Zieve, F.

PY - 2007/7/1

Y1 - 2007/7/1

N2 - Background: Mitemcinal, an oral motilin agonist, accelerates gastric emptying. Aim: To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. Methods: In a randomized, double-blind design, 392 insulin-requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period. Results: Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels. Conclusions: Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.

AB - Background: Mitemcinal, an oral motilin agonist, accelerates gastric emptying. Aim: To investigate if mitemcinal was superior to placebo in relief of symptoms attributed to gastroparesis. Methods: In a randomized, double-blind design, 392 insulin-requiring diabetics with symptoms attributable to gastroparesis were treated for 3 months with placebo, mitemcinal 5 or 10 mg bid. On a weekly basis, patients assessed whether there was adequate relief of their gastroparesis symptoms. Patients were classified as Complete Responders (CR) if there were three consecutive positive monthly responses, which required at least 50% of their weekly responses in a month being positive. An Overall Responder (OR) had at least 75% positive weekly responses for the whole treatment period. Results: Mitemcinal 10 mg produced a significantly better response rate than placebo with a 10.6% increase in the OR (P < 0.05 vs. placebo). Mitemcinal 10 mg also produced statistically significant increases in the CR and OR in the subgroup identified by baseline body mass index (<35 kg/m2) and haemoglobin A1c (<10%) (P < 0.01 vs. placebo). Adverse events did not differ from placebo frequency levels. Conclusions: Mitemcinal can induce a statistically significant response to treatment in a subset of diabetic gastroparesis where future prokinetic clinical trials should be focused.

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