Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

NCT01135368 | Completed Phase 4 Results

• 2 other identifiers: AGO K019U1111-1115-1139
• Study Type: interventional
• Target: 506
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

Conditions

Gastroesophageal Reflux

Keywords

GERD; Gastroesophageal Reflux Disease; Drug Therapy

Outcome Measures

Primary Outcomes (7)

• Change From Baseline in Reflux Disease Symptom - Heartburn

  Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.

  Baseline and Week 8

• Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation

  Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.

  Baseline and Week 8

• Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing

  Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.

  Baseline and Week 8

• Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen

  Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.

  Baseline and Week 8

• Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting

  Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.

  Baseline and Week 8

• Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat

  Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients.

  Baseline and Week 8

• Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy

  Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks \>5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are \<75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows).

  Baseline and Week 8

Secondary Outcomes (29)

• Change From Baseline in Enterochromaffin-like Cell Hyperplasia

  Baseline and Year 5

• Change From Baseline in Antrum Atrophy

  Baseline and Year 5

• Change From Baseline in Corpus Atrophy

  Baseline and Year 5

• Change From Baseline in Average Antrum Chronic Inflammation Score

  Baseline and Year 5

• Change From Baseline in Corpus Chronic Inflammation Score

  Baseline and Year 5

Study Arms (1)

Lansoprazole

EXPERIMENTAL

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.

Drug: Lansoprazole

Interventions

Lansoprazole DRUG

Lansoprazole capsules

Also known as: Prevacid, Helicid, Zoton, Inhibitol, Agopton, AG-1749

Lansoprazole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had Gastro Esophageal Reflux disease with or without oesophagitis.
• Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.

You may not qualify if:

• History of surgery of stomach or oesophagus.
• Gastric ulcer (can be included after healing of gastric ulcer).
• Duodenal ulcer (can be included after healing of duodenal ulcer).
• Bleeding (melena, hematemesis).
• Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
• Barrett oesophagus with dysplasia.
• Complicated esophagitis (oesophageal strictures or ulcers).
• Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
• Pregnancy, wish to become pregnant, breast feeding.
• Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) \> 100 mg/day.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Lansoprazole; helicide

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2002
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 3, 2012
• Results First Posted: September 3, 2012

Record last verified: 2012-07