Phase 4 N=506 Treatment

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease

Gastroesophageal Reflux

Bottom Line

View on ClinicalTrials.gov: NCT01135368 ↗

Enrolled (actual)

506

Serious AEs

16.2%

Results posted

Sep 2012

Primary outcome: Primary: Change From Baseline in Reflux Disease Symptom - Heartburn — 59; 117; 186; 7 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lansoprazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Reflux Disease Symptom - Heartburn	59; 117; 186; 7; 27; 43	—
PRIMARY Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation	58; 113; 125; 81; 4; 19	—
PRIMARY Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing	293; 89; 33; 13; 7; 9	—
PRIMARY Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen	124; 125; 86; 44; 9; 19	—
PRIMARY Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting	303; 78; 25; 13; 10; 9	—
PRIMARY Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat	305; 71; 24; 14; 16; 4	—
PRIMARY Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy	38; 97; 79; 17; 4; 0	—
SECONDARY Change From Baseline in Enterochromaffin-like Cell Hyperplasia	315; 8; 1; 26; 10; 2	—
SECONDARY Change From Baseline in Antrum Atrophy	306; 23; 4; 1; 23; 7	—
SECONDARY Change From Baseline in Corpus Atrophy	330; 12; 1; 17; 9; 0	—
SECONDARY Change From Baseline in Average Antrum Chronic Inflammation Score	0.8; -0.2	—
SECONDARY Change From Baseline in Corpus Chronic Inflammation Score	0.4; -0.0	—
SECONDARY Change From Baseline in Antrum Intestinal Metaplasia	319; 13; 4; 23; 6; 2	—
SECONDARY Change From Baseline in Corpus Intestinal Metaplasia	359; 1; 18; 1; 2; 0	—
SECONDARY Change From Baseline in Blood Analysis - Testosterone	4.57; 0.16	—
SECONDARY Change From Baseline in Blood Analysis - Luteinizing Hormone	4.73; 0.71	—
SECONDARY Change From Baseline in Blood Analysis - Follicle Stimulating Hormone	7.62; 0.39	—
SECONDARY Ophthalmologic Examination - Visual Acuity	0.927; 0.904; 0.919; 0.894	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare	62; 1; 4; 73; 0; 4	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Adaptation With Glare	75; 2; 12; 58; 2; 4	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Accommodation	2.877; -0.090; 2.835; -0.073	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Color Vision	46; 76; 5; 12; 320; 10	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye	46; 78; 3; 11; 343; 5	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye	46; 77; 4; 11; 348; 5	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye	46; 56; 25; 8; 193; 7	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye	46; 56; 25; 6; 193; 8	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye	46; 73; 8; 11; 338; 2	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye	47; 73; 7; 12; 341; 3	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye	48; 80; 0; 11; 356; 1	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye	46; 80; 1; 11; 361; 1	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye	48; 76; 4; 11; 337; 4	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye	46; 75; 6; 11; 339; 4	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye	48; 68; 12; 7; 279; 6	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye	46; 68; 13; 7; 278; 7	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye	49; 75; 4; 10; 317; 3	—
SECONDARY Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye	46; 77; 4; 10; 323; 5	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01135368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.