Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms

NCT01990339 | Completed Results

• 3 other identifiers: 467-531JapicCTI-132310JapicCTI-R140645
• Study Type: observational
• Target: 14,965
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms

Conditions

Gastroesophageal Reflux Disease With Dyspepsia Symptoms

Outcome Measures

Primary Outcomes (1)

• Subjective Symptom Improvement Rate

  Subjective symptoms were evaluated as "Disappeared," "Improved," "No change," "Worsened," or "Unclear." These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of "Disappeared" + "Improved") was calculated for each symptom. The percentage of participants with Improvement by symptom was reported.

  Start of treatment and Week 4

Secondary Outcomes (1)

• Frequency of Adverse Events (Adverse Drug Reactions)

  4 Weeks

Study Arms (1)

Lansoprazole

Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.

Drug: Lansoprazole

Interventions

Lansoprazole DRUG

• Reflux esophagitis The usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. • Nonerosive gastroesophageal reflux disease Non-erosive gastroesophageal reflux disease The usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.

Also known as: Takepron

Lansoprazole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastroesophageal reflux disease with dyspepsia symptoms

You may qualify if:

• Patients with heartburn or acid regurgitation at the start of Takepron administration\* , or patients without heartburn and acid regurgitation, but with endoscopic findings classified as Los Angeles grade A-D at the start of Takepron therapy.
• Patients with symptoms of dyspepsia (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, upper abdominal bloating, nausea/vomiting, or belching) at the start of Takepron administration\* \*These patients must have answered "never, " "sometimes/mild," "often/moderate," or "frequent/severe" on a 4-point scale questionnaire about subjective symptoms.

You may not qualify if:

• Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks before the start of Takepron administration
• Patients taking antidepressants

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Interventions

Lansoprazole

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

Limitations and Caveats

There were no control groups in this single-arm study. The observed subjective symptom improvement rates and frequency of adverse drug reactions may be used in an exploratory manner to understand drug use but cannot be treated as verified results.

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 27, 2016
• Results First Posted: November 11, 2014

Record last verified: 2016-09