NEWS HIGHLIGHTS
Published Studies Related to Kapidex (Dexlansoprazole)
The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. [2011.03]
OBJECTIVES: Nocturnal heartburn and related sleep disturbances are common among patients with gastroesophageal reflux disease (GERD). This study evaluated the efficacy of dexlansoprazole MR 30 mg in relieving nocturnal heartburn and GERD-related sleep disturbances, improving work productivity, and decreasing nocturnal symptom severity in patients with symptomatic GERD... CONCLUSIONS: In patients with symptomatic GERD, dexlansoprazole MR 30 mg is significantly more efficacious than placebo in providing relief from nocturnal heartburn, in reducing GERD-related sleep disturbances and the consequent impairments in work productivity, and in improving sleep quality/quality of life.
The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. [2011.02]
BACKGROUND: Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole, designed to extend the duration of acid suppression. AIM: To assess the 12-month safety of dexlansoprazole MR in patients with symptomatic gastro-oesophageal reflux disease (GERD)... CONCLUSIONS: Twelve-month treatment with dexlansoprazole MR 60 and 90 mg was well tolerated by GERD patients in this study (Clinicaltrials.gov identifier NCT00255190). (c) 2010 Blackwell Publishing Ltd.
Lack of electrocardiographic effect of dexlansoprazole MR, a novel modified-release formulation of the proton pump inhibitor dexlansoprazole, in healthy participants. [2009.12]
The effect of the proton pump inhibitor dexlansoprazole, an enantiomer of lansoprazole, on QT intervals was assessed after oral administration of a modified-release formulation of dexlansoprazole (dexlansoprazole MR). In this randomized, positive-comparator, placebo-controlled, 4-period crossover study, 40 healthy participants received single doses of dexlansoprazole MR 90 mg, dexlansoprazole MR 300 mg, moxifloxacin 400 mg, and placebo separated by 5-day washout intervals...
Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. [2009.11.15]
BACKGROUND: Dexlansoprazole MR is a dual delayed release formulation of dexlansoprazole, an enantiomer of lansoprazole. AIM: To assess safety of dexlansoprazole MR in phase 3 clinical trials... CONCLUSION: Dexlansoprazole MR 30-90 mg has a safety profile comparable to that of lansoprazole.
Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. [2009.09.04]
SUMMARY Background Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole. Aim To assess safety of dexlansoprazole MR in phase 3 clinical trials Methods Data from 4270 patients receiving dexlansoprazole MR 30 mg (n=455), 60 mg (n=2311), or 90 mg (n=1864); lansoprazole 30 mg (n=1363); or placebo (n=896) in 6 randomized controlled trials and a 12-month safety study were pooled...
Clinical Trials Related to Kapidex (Dexlansoprazole)
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease [Recruiting]
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole,
once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
Effect of Dexlansoprazole on Bone Homeostasis [Recruiting]
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are
effective in rendering patients with existing type 1 diabetes, insulin independent. This
four-arm study was designed to evaluate the safety and efficacy for insulin independence by
utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved
proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase
gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell
formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).
Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among
recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as
67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.
1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further
autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was
ultimately required by all patients. Therefore, this study proposes the usage of
cyclosporine with a beta regeneration agent.
Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20
months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res
Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor
demonstrated reductions in daily insulin requirements by much as 75% within 3 months
following four weeks of therapy among existing type 1 diabetes patients (Transition
Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed
January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing
autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown
to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth
factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).
Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune
tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been
successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.
2007;1103: 19-32). The distinctions and complexities of islets in man are far different than
that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of
print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration
agent are required to sustain insulin independence.
Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to
10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This
study will determine the safety and efficacy of cyclosporine used with and without
lansoprazole to determine the impact on insulin independence among patients with existing
type 1 diabetes.
Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The
combination of the two therapies may render reductions in insulin requirements and have a
greater impact on sustained insulin independence than previously reported with cyclosporine
or gastrin alone among type 1 patients.
This 12-week study consists of four treatment arms:
- Oral Cyclosporine/Placebo
- Oral Lansoprazole/Placebo
- Oral Lansoprazole/Oral Cyclosporine
- Oral Placebo/Oral Placebo
It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will
safely render significantly more patients with existing type 1 diabetes, insulin independent
and may serve as a novel and innovative treatment approach for patients with type 1 diabetes
utilizing two FDA-approved therapies.
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are
effective in rendering recent onset type 1 diabetes patients, insulin independent. This
four-arm study was designed to evaluate the safety and efficacy for insulin independence by
utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved
proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase
gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell
formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).
Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among
recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as
67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.
1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further
autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was
ultimately required by all patients. Therefore, this study proposes the usage of
cyclosporine with a beta regeneration agent.
Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20
months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res
Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor
demonstrated reductions in daily insulin requirements by much as 75% within 3 months
following four weeks of therapy among existing type 1 diabetes patients (Transition
Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed
January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing
autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown
to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth
factor in in-vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).
Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune
tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been
successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.
2007;1103: 19-32). The distinctions and complexities of islets in man are far different than
that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of
print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration
agent are required to sustain insulin independence.
Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to
10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This
study will determine the safety and efficacy of cyclosporine used with and without
lansoprazole to determine the impact on insulin independence among recently diagnosed
patients with type 1 diabetes.
Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The
combination of the two therapies may render reductions in insulin requirements and have a
greater impact on sustained insulin independence than previously reported with cyclosporine
or gastrin alone among type 1 patients.
This 12-week study consists of four treatment arms:
- Oral Cyclosporine/Placebo
- Oral Lansoprazole/Placebo
- Oral Lansoprazole/Oral Cyclosporine
- Oral Placebo/Oral Placebo
It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will
safely render significantly more patients with existing type 1 diabetes, insulin independent
and may serve as a novel and innovative treatment approach for recently diagnosed patients
with type 1 diabetes utilizing two FDA-approved therapies.
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents [Recruiting]
The purpose of this study is to assess the safety and effectiveness of treatment with once
daily oral administration of dexlansoprazole delayed-release capsules in adolescents with
erosive esophagitis (EE) and for maintenance of healed EE and relief of heartburn.
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