Nexium for Esophagitis

(EE Trial)

Recruiting at 39 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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

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.

What data supports the effectiveness of the drug Nexium for treating esophagitis?

Research shows that esomeprazole (Nexium) is effective in treating gastroesophageal reflux disease and healing erosive esophagitis, providing better acid control and higher healing rates compared to other similar drugs. In clinical trials, esomeprazole 40 mg once daily for up to 8 weeks resulted in higher healing rates of erosive esophagitis and more sustained heartburn relief than omeprazole or lansoprazole. ^{1 2 3 4 5}

How does the drug Nexium differ from other treatments for esophagitis?

Nexium (esomeprazole) is unique because it is a proton pump inhibitor that provides more effective acid control than other similar drugs, maintaining stomach acidity at a lower level for longer periods. It offers higher rates of healing for erosive esophagitis and better maintenance of healing compared to other treatments like omeprazole and lansoprazole. ^{1 2 3 5 6}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physical and chemical stability of esomeprazole sodium solutions. [2022]

2. Switzerland 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]. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Network meta-analysis of multiple doses of vonoprazan for the treatment of erosive esophagitis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Esomeprazole tablet vs omeprazole capsule in treating erosive esophagitis. [2019]

6. Bulgaria 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]. [2018]