Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy

Francis G. LeVeque, Jeanne B. Parzuchowski, George C. Farinacci, Spencer W. Redding, Brad Rodu, Jonas T. Johnson, Gerald A. Ferretti, Peter D. Eisenberg, Michael B. Zimmer

Research output: Contribution to journalArticle

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Abstract

Purpose: This open-label, multicenter trial evaluated the efficacy of a mucoadherent, anesthetic medication (MGI 209) for relief from painful oral ulcers associated with cytotoxic chemotherapy. Patients and Methods: Twenty-eight eligible cancer patients who had up to five discrete oral ulcers (total area ≤ 5 cm2) completed this study. Mean age was 53.5 years (range, 21 to 81). Subjective assessments of oral discomfort before and after an orange juice pain challenge (OJPC), which was measured using a visual analog scale (VAS), and visual estimates of the amount of MGI 209 that remained on treated ulcers were collected at (1) baseline (before MGI 209 treatment); and (2) 30, 60, 120, and 180 minutes posttreatment. Results: Most subjects had low VAS scores (4 or less), which was indicative of oral discomfort, at baseline before and after the OJPC. At 30, 60, 120, and 180 minutes after MGI 209 treatment, most subjects had high VAS scores before and after an OJPC compared with baseline scores, which was indicative of a substantial increase in oral comfort; these differences were statistically significant (P < .0001). Mean percent of MGI 209 estimated to remain on ulcers at the previously mentioned times was 93.7%, 90.3%, 79.6%, and 71.3% of the total amount applied, respectively. Conclusion: Benzocaine hydrochloride in combination with the protective, mucoadherent film-coating relieved discomfort for at least 3 hours even with exposure to an irritating beverage. MGI 209 treatment should allow patients with chemotherapy-induced oral ulcers to drink and eat with significantly diminished pain or no pain.

Original languageEnglish (US)
Pages (from-to)1963-1968
Number of pages6
JournalJournal of Clinical Oncology
Volume10
Issue number12
StatePublished - 1992
Externally publishedYes

Fingerprint

Oral Ulcer
Anesthetics
Drug Therapy
Pain
Visual Analog Scale
Ulcer
Benzocaine
Beverages
Multicenter Studies
MGI 209
Therapeutics
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

LeVeque, F. G., Parzuchowski, J. B., Farinacci, G. C., Redding, S. W., Rodu, B., Johnson, J. T., ... Zimmer, M. B. (1992). Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy. Journal of Clinical Oncology, 10(12), 1963-1968.

Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy. / LeVeque, Francis G.; Parzuchowski, Jeanne B.; Farinacci, George C.; Redding, Spencer W.; Rodu, Brad; Johnson, Jonas T.; Ferretti, Gerald A.; Eisenberg, Peter D.; Zimmer, Michael B.

In: Journal of Clinical Oncology, Vol. 10, No. 12, 1992, p. 1963-1968.

Research output: Contribution to journalArticle

LeVeque, FG, Parzuchowski, JB, Farinacci, GC, Redding, SW, Rodu, B, Johnson, JT, Ferretti, GA, Eisenberg, PD & Zimmer, MB 1992, 'Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy', Journal of Clinical Oncology, vol. 10, no. 12, pp. 1963-1968.
LeVeque FG, Parzuchowski JB, Farinacci GC, Redding SW, Rodu B, Johnson JT et al. Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy. Journal of Clinical Oncology. 1992;10(12):1963-1968.
LeVeque, Francis G. ; Parzuchowski, Jeanne B. ; Farinacci, George C. ; Redding, Spencer W. ; Rodu, Brad ; Johnson, Jonas T. ; Ferretti, Gerald A. ; Eisenberg, Peter D. ; Zimmer, Michael B. / Clinical evaluation of MGI 209, an anesthetic, film-forming agent for relief from painful oral ulcers associated with chemotherapy. In: Journal of Clinical Oncology. 1992 ; Vol. 10, No. 12. pp. 1963-1968.
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abstract = "Purpose: This open-label, multicenter trial evaluated the efficacy of a mucoadherent, anesthetic medication (MGI 209) for relief from painful oral ulcers associated with cytotoxic chemotherapy. Patients and Methods: Twenty-eight eligible cancer patients who had up to five discrete oral ulcers (total area ≤ 5 cm2) completed this study. Mean age was 53.5 years (range, 21 to 81). Subjective assessments of oral discomfort before and after an orange juice pain challenge (OJPC), which was measured using a visual analog scale (VAS), and visual estimates of the amount of MGI 209 that remained on treated ulcers were collected at (1) baseline (before MGI 209 treatment); and (2) 30, 60, 120, and 180 minutes posttreatment. Results: Most subjects had low VAS scores (4 or less), which was indicative of oral discomfort, at baseline before and after the OJPC. At 30, 60, 120, and 180 minutes after MGI 209 treatment, most subjects had high VAS scores before and after an OJPC compared with baseline scores, which was indicative of a substantial increase in oral comfort; these differences were statistically significant (P < .0001). Mean percent of MGI 209 estimated to remain on ulcers at the previously mentioned times was 93.7{\%}, 90.3{\%}, 79.6{\%}, and 71.3{\%} of the total amount applied, respectively. Conclusion: Benzocaine hydrochloride in combination with the protective, mucoadherent film-coating relieved discomfort for at least 3 hours even with exposure to an irritating beverage. MGI 209 treatment should allow patients with chemotherapy-induced oral ulcers to drink and eat with significantly diminished pain or no pain.",
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AU - Parzuchowski, Jeanne B.

AU - Farinacci, George C.

AU - Redding, Spencer W.

AU - Rodu, Brad

AU - Johnson, Jonas T.

AU - Ferretti, Gerald A.

AU - Eisenberg, Peter D.

AU - Zimmer, Michael B.

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N2 - Purpose: This open-label, multicenter trial evaluated the efficacy of a mucoadherent, anesthetic medication (MGI 209) for relief from painful oral ulcers associated with cytotoxic chemotherapy. Patients and Methods: Twenty-eight eligible cancer patients who had up to five discrete oral ulcers (total area ≤ 5 cm2) completed this study. Mean age was 53.5 years (range, 21 to 81). Subjective assessments of oral discomfort before and after an orange juice pain challenge (OJPC), which was measured using a visual analog scale (VAS), and visual estimates of the amount of MGI 209 that remained on treated ulcers were collected at (1) baseline (before MGI 209 treatment); and (2) 30, 60, 120, and 180 minutes posttreatment. Results: Most subjects had low VAS scores (4 or less), which was indicative of oral discomfort, at baseline before and after the OJPC. At 30, 60, 120, and 180 minutes after MGI 209 treatment, most subjects had high VAS scores before and after an OJPC compared with baseline scores, which was indicative of a substantial increase in oral comfort; these differences were statistically significant (P < .0001). Mean percent of MGI 209 estimated to remain on ulcers at the previously mentioned times was 93.7%, 90.3%, 79.6%, and 71.3% of the total amount applied, respectively. Conclusion: Benzocaine hydrochloride in combination with the protective, mucoadherent film-coating relieved discomfort for at least 3 hours even with exposure to an irritating beverage. MGI 209 treatment should allow patients with chemotherapy-induced oral ulcers to drink and eat with significantly diminished pain or no pain.

AB - Purpose: This open-label, multicenter trial evaluated the efficacy of a mucoadherent, anesthetic medication (MGI 209) for relief from painful oral ulcers associated with cytotoxic chemotherapy. Patients and Methods: Twenty-eight eligible cancer patients who had up to five discrete oral ulcers (total area ≤ 5 cm2) completed this study. Mean age was 53.5 years (range, 21 to 81). Subjective assessments of oral discomfort before and after an orange juice pain challenge (OJPC), which was measured using a visual analog scale (VAS), and visual estimates of the amount of MGI 209 that remained on treated ulcers were collected at (1) baseline (before MGI 209 treatment); and (2) 30, 60, 120, and 180 minutes posttreatment. Results: Most subjects had low VAS scores (4 or less), which was indicative of oral discomfort, at baseline before and after the OJPC. At 30, 60, 120, and 180 minutes after MGI 209 treatment, most subjects had high VAS scores before and after an OJPC compared with baseline scores, which was indicative of a substantial increase in oral comfort; these differences were statistically significant (P < .0001). Mean percent of MGI 209 estimated to remain on ulcers at the previously mentioned times was 93.7%, 90.3%, 79.6%, and 71.3% of the total amount applied, respectively. Conclusion: Benzocaine hydrochloride in combination with the protective, mucoadherent film-coating relieved discomfort for at least 3 hours even with exposure to an irritating beverage. MGI 209 treatment should allow patients with chemotherapy-induced oral ulcers to drink and eat with significantly diminished pain or no pain.

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