Last reviewed · How we verify
NCT01129713
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).
Phase 1/Phase 2 trial testing Secretol in Gastroesophageal Reflux Disease (GERD) in 40 participants. Status unknown.
1 May 2015
Quick facts
| Lead sponsor | Effexus Pharmaceutical |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 May 2010 |
| Primary completion | 1 May 2015 |
| Estimated completion | 1 May 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Gastroesophageal Reflux Disease (GERD) — all drugs for Gastroesophageal Reflux Disease (GERD) →
- Heartburn — all drugs for Heartburn →
- Indigestion — all drugs for Indigestion →
Sponsor
Effexus Pharmaceutical — full company profile →
Who can join
Adults 18 to 75, any sex, with Gastroesophageal Reflux Disease (GERD) or 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.
-
Primary objective is to evaluate the relationship between healing and study drug allotment.
Time frame: 3 weeks of treatment
The primary objective is to evaluate the relationship between healing and study drug allotment. The variables to be used are erosive esophagitis healing status after 3 weeks of treatment as assessed by EGD (upper endoscopy) comparing to base line EGD.
Sponsor's own description
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01129713
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroesophageal Reflux Disease (GERD)
Currently open trials in the same condition.
- NCT02616302 — A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux · Phase 2 · recruiting
- NCT07174882 — Evaluation of the Clinical Course of NERD and Assessment of the Esophageal Mucosa Resistance · active not recruiting
- NCT05870163 — Post-Market Registry for the Evaluation of RefluxStop in GERD Treatment · recruiting
- NCT06862037 — Development of Machine Learning Models to Predict Postoperative GERD Symptom Resolution After Laparoscopic Nissen Fundop · active not recruiting
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 NCT01129713 (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 Effexus Pharmaceutical
- Last refreshed: 4 August 2014
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/NCT01129713.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing