Nexium for Esophagitis

(EE Trial)

Recruiting at 44 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: PPIs, H2-receptor antagonists

Disqualifiers: Severe heart, lung, liver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two doses of Nexium, a proton pump inhibitor, to evaluate their effectiveness in maintaining esophageal health in young children with erosive esophagitis (EE). EE occurs when the esophagus lining is damaged, often due to acid reflux, causing pain and discomfort. The trial compares low and high doses of Nexium to determine which is more effective and safe. Children aged 1 to 11 with GERD symptoms for at least three months and a diagnosis of EE may qualify for this study. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to a treatment nearing potential widespread use.

Do I need to stop my current medications to join the trial?

The trial requires that you do not take other proton pump inhibitors (PPIs) or H2-receptor antagonists while participating. If you are currently taking these medications, you may need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Nexium, a medication for treating erosive esophagitis, is generally safe for patients. Past studies tested Nexium on children aged 1 to 11 years and found it safe for short-term use, indicating its prior safe use in kids.

For the low dose of 10mg, various clinical trials have proven Nexium safe. Only a few mild side effects, such as headaches and stomach pain, were reported. These are common with many medications and usually not serious.

The higher dose of 20mg has also been well-tolerated. It was tested in both short-term and long-term studies. Some people experienced minor side effects like nausea or diarrhea, but these were not common.

Overall, existing research supports that Nexium is safe for children between 1 and 11 years old when used as directed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for esophagitis, like proton pump inhibitors (PPIs) such as omeprazole or lansoprazole, generally provide relief by reducing stomach acid over time. Nexium, or esomeprazole, stands out because it’s a more targeted PPI that can offer faster healing. Researchers are excited about the potential of Nexium because it’s designed to be more effective at a lower dose, which might mean fewer side effects and a quicker response. In particular, the high-dose Nexium could provide rapid relief and healing for esophagitis, making it an attractive option for those who need swift symptom control.

What is the effectiveness track record for Nexium in treating esophagitis?

Research has shown that Nexium (esomeprazole) effectively heals esophagus damage caused by acid reflux, known as erosive esophagitis (EE). One study found that 93% of patients with varying levels of EE healed after 8 weeks of taking Nexium, compared to 89% who took omeprazole, another treatment option. This trial will compare two different doses of Nexium: a low dose and a high dose. Previous studies demonstrate Nexium's strong ability to heal the esophagus and relieve symptoms of gastroesophageal reflux disease (GERD). Additionally, other studies have found that Nexium significantly improves GERD symptoms compared to a placebo. These findings suggest that Nexium can be a reliable option for maintaining healing in children with EE. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for children aged 1 to 11 with a history of GERD and confirmed erosive esophagitis (EE). They must have healed EE after an initial treatment phase. Participants need to weigh at least 10 kg, be able to follow contraception guidelines if applicable, and not have severe other diseases or conditions requiring surgery during the study.

Inclusion Criteria

My endoscopy confirmed EE within a week before starting the healing phase.

My esophagus healed after treatment, confirmed by an endoscopy.

I weigh at least 10 kilograms.

Exclusion Criteria

I have not been seriously ill in the last 4 weeks.

Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.

Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Healing

Participants receive Nexium to heal erosive esophagitis

8 weeks

Maintenance

Participants receive Nexium to maintain healing of erosive esophagitis

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nexium 10mg
• Nexium 20mg

Trial Overview The study tests whether Nexium at doses of either 10mg or 20mg is effective in keeping erosive esophagitis from coming back in young patients who've already been treated for it. The safety of Nexium will also be monitored throughout the trial.

How Is the Trial Designed?

Group I: Nexium - Low dose Active Control 1 Intervention

Arm 2 (Low dose = ½ healing dose)

Group II: Nexium - high dose Active Control 1 Intervention

Arm 1 (High dose = Healing dose)

Nexium 10mg is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis
• Zollinger-Ellison syndrome
• Peptic ulcer disease

Approved in European Union as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis
• Zollinger-Ellison syndrome
• Peptic ulcer disease

Approved in Canada as Nexium for:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis
• Zollinger-Ellison syndrome
• Peptic ulcer disease

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Little Journey Ltd.

Collaborator

Trials

1

Recruited

100+

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+

IQVIA RDS Inc.

Industry Sponsor

Trials

7

Recruited

14,700+

CISCRP

Industry Sponsor

Trials

4

Recruited

1,400+

IQVIA RDS Inc.

Collaborator

Trials

4

Recruited

14,400+

Calyx

Collaborator

Trials

2

Recruited

250+

Quipment Inc.

Collaborator

Trials

1

Recruited

100+

Thermo Fisher Scientific, Inc

Industry Sponsor

Trials

25

Recruited

21,500+

Medidata Solutions

Industry Sponsor

Trials

25

Recruited

25,600+

Published Research Related to This Trial

In a study of 1904 patients with symptoms of gastroesophageal reflux disease (GERD), continuous daily treatment with esomeprazole 20 mg provided slightly better relief from heartburn compared to on-demand treatment.

However, the on-demand use of esomeprazole 20 mg resulted in lower direct medical costs, making it a more economical option while still being well tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term treatment of patients with symptomatic gastroesophageal reflux disease comparing costs and efficacy over 6 months of treatment with Nexium On-Demand Treatment or Nexium continuous treatment. An open, randomised multi-center study]. Beglinger, C., Thalmann, C., Szucs, T., et al.[2013]

In a study of 47 mechanically ventilated patients at high risk for stress ulcers, intravenous esomeprazole effectively maintained gastric acidity above pH 5 and prevented bleeding of the gastric mucosa, demonstrating its safety and efficacy as a preventive treatment.

No instances of gastric mucosal bleeding were observed, and the study suggests that esomeprazole could be a reliable option for preventing stress ulcers in ICU patients, although further comparative studies with other treatments are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency and safety of the intravenous application of esomeprazole (nexium - Astra Zeneca) in high risk patients subjected to mechanic ventilation]. Stefanov, Ch., Batashki, I., Dimitrov, D., et al.[2018]

Esomeprazole (Nexium) is more effective than other proton pump inhibitors in controlling stomach acid, maintaining a higher intragastric pH for longer periods in patients with gastroesophageal reflux disease after just 5 days of treatment.

In clinical trials, esomeprazole 40 mg once daily for up to 8 weeks resulted in higher healing rates of erosive esophagitis and better heartburn resolution compared to omeprazole and lansoprazole, making it a strong option for treating acid-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of esomeprazole in patients with acid-peptic disorders. Beck, J.[2019]

A network meta-analysis of various doses of vonoprazan (VPZ) found that both 20 mg and 40 mg doses are effective for treating erosive esophagitis, showing comparable healing rates to standard proton pump inhibitors (PPIs).

While all doses had similar treatment-emergent adverse events (TEAEs), the 40 mg dose of vonoprazan demonstrated the best healing rates and safety profile, while the 20 mg dose had the highest rate of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network meta-analysis of multiple doses of vonoprazan for the treatment of erosive esophagitis. He, J., Gao, Y., Bai, G., et al.[2023]

Esomeprazole sodium remains chemically and physically stable for at least 2 days at room temperature and 5 days when refrigerated, making it suitable for short-term infusion use.

The study found no significant loss of drug content (less than 7%) in esomeprazole samples across various infusion solutions, indicating its reliability for treating gastroesophageal reflux disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and chemical stability of esomeprazole sodium solutions. Kupiec, TC., Aloumanis, V., Ben, M., et al.[2022]

In a study involving 48 Chinese patients with erosive/ulcerative reflux esophagitis, esomeprazole (40 mg) showed a healing rate of 72.7%, compared to 50.0% for omeprazole (20 mg), although this difference was not statistically significant (P = 0.204).

Both esomeprazole and omeprazole were found to be safe, with similar rates of adverse effects (28% for esomeprazole and 26.1% for omeprazole), indicating that esomeprazole is at least as effective and safe as omeprazole for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esomeprazole tablet vs omeprazole capsule in treating erosive esophagitis. Chen, CY., Lu, CL., Luo, JC., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8215048/

Efficacy and Safety of Esomeprazole for the Treatment of ... Esomeprazole treatment yielded a significant improvement in clinical signs and symptoms of GERD compared to placebo group.

2. purplepill.com purplepill.com/hcp/healing-of-ee.html

Healing of EE | NEXIUM® (esomeprazole magnesium) In GERD patients with varying grades of EE through 8 weeks, 93% of patients were healed with NEXIUM 40 mg QD (n=2624) vs 89% with omeprazole 30 mg QD (n=2617) ( ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00251927?term=Esomeprazole&viewType=Table&rank=6

NCT00251927 | Esomeprazole (NEXIUM) vs. Surgery The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002927000023935

Efficacy and safety of esomeprazole compared with ... The results of this study indicate that esomeprazole provides a significant advantage over omeprazole in terms of esophageal healing and relief of heartburn in ...

5. gutnliver.org gutnliver.org/journal/view.html?volume=17&number=2&spage=226

A Randomized, Double-Blind, Active-Control, Noninferiority ... In conclusion, our results indicate that EsoduoR 20/800 mg is effective and safe for 4-week treatment of heartburn and acid regurgitation in ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/022101s014021957s017021153s050lbl.pdf

NEXIUM (esomeprazole magnesium) Label The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/esomeprazole-oral-route/description/drg-20074322

Esomeprazole (oral route) - Side effects & dosage Esomeprazole is used to treat conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/021153s056,021957s023,022101s020lbl.pdf

NEXIUM (esomeprazole magnesium) Label The safety and effectiveness of NEXIUM for delayed-release oral suspension have been established in pediatric patients 1 year to 11 years of age for the short- ...

9. webmd.com webmd.com/drugs/2/drug-20536/nexium-oral/details

Esomeprazole (Nexium) - Uses, Side Effects, and More Find patient medical information for Esomeprazole (Nexium) on WebMD including its uses, side effects and safety, interactions, pictures,

10. astrazeneca.ca astrazeneca.ca/content/dam/az-ca/downloads/productinformation/nexium-product-monograph-en.pdf

nexium-product-monograph-en.pdf acid regurgitation, without esophagitis, the recommended dose is 10 mg NEXIUM once daily for up to 8 weeks. Doses over 1 mg/kg/day have not ...