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NCT00389948
A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn
Phase 3 trial testing Lanzoprazole in Heartburn in 576 participants. Completed in 1 January 2007.
Quick facts
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 576 |
| Start date | 1 June 2006 |
| Estimated completion | 1 January 2007 |
| Sites | 28 locations across United States |
Drugs / interventions tested
- Lanzoprazole — full drug profile →
Conditions studied
- Heartburn — all drugs for Heartburn →
Sponsor
Novartis — full company profile →
Who can join
18 and older, any sex, with Heartburn. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To demonstrate that repeated daily doses of 15 mg of lansoprazole are effective in increasing the proportion of days with no heartburn during study treatment, when compared to placebo.
Sponsor's own description
Heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00389948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heartburn
Currently open trials in the same condition.
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- NCT05629143 — Primary carE PPi dEprescRibing Trial · Phase 4 · active not recruiting
- NCT01696734 — Domperidone in Treating Patients With Gastrointestinal Disorders · Phase 3 · recruiting
Other Novartis trials
Trials by the same sponsor.
- NCT06595069 — A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients · completed
- NCT06632730 — Therapeutic Management and Use of Resources and Costs of Spinal Muscular Atrophy in Spain · completed
- NCT06395909 — A Study to Assess the Effectiveness and Safety of Mayzent in Chinese Patients With Relapsing Forms of Multiple Sclerosis · completed
- NCT06516029 — Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Ascimini · completed
- NCT06644638 — Real-World Persistence and Adherence of Ofatumumab Compared to Self-Injectable and Oral DMTs in Patients With Multiple S · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00389948 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novartis
- Last refreshed: 13 April 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00389948.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing