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Dexilant (Dexlansoprazole) - Summary

 
 



DEXILANT SUMMARY

The active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers).

Healing of Erosive Esophagitis

DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

Maintenance of Healed Erosive Esophagitis

DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to six months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease

DEXILANT is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.


See all Dexilant indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Dexilant (Dexlansoprazole)

Distinguishing the impact of dexlansoprazole on heartburn vs. regurgitation in patients with gastro-oesophageal reflux disease. [2013]
(EE)... CONCLUSIONS: Dexlansoprazole appears to be effective in improving both heartburn

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.

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Clinical Trials Related to Dexilant (Dexlansoprazole)

Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain [Withdrawn]
The purpose of this study is to investigate a new treatment for non-cardiac chest pain (NCCP) related to gastrointestinal reflux disease (GERD), called Dexilant. The investigators would like to test its effectiveness in treating NCCP. The patient will undergo esophageal balloon distention testing (EBDT) before and after taking the new treatment for one month (Dexilant). EBDT evaluates the sensation and mechanical properties of the esophagus. A catheter with a deflated balloon is placed through the mouth and into the esophagus and the balloon is inflated with water. ECG and labs will be done throughout the study as a measurement of safety.

Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants [Completed]
The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue and swallowed without water.

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 [Completed]
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.

A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA) [Completed]
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)

Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 Months [Not yet recruiting]
The purpose of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) [after daily administration for 7 days] and safety [after daily administration for 8 weeks] of dexlansoprazole in pediatric participants aged 1 to 11 months, inclusive, with acid-related diseases.

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Reports of Suspected Dexilant (Dexlansoprazole) Side Effects

Dizziness (13)Dyspnoea (13)Drug Ineffective (11)Diarrhoea (10)Gastrooesophageal Reflux Disease (9)Abdominal Pain Upper (8)Asthenia (8)Oropharyngeal Pain (7)Fatigue (7)Arthralgia (7)more >>


Page last updated: 2014-11-30

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