Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

Browse trials for

• Gastroesophageal Reflux 1,067

Keywords

• Gastroesophageal Reflux Disease
• Acid Reflux

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 3,029 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Study arms

• Experimental
  Esomeprazole 20 mg Once Daily (initial phase)

  Drug: esomeprazole (Nexium®)

• Experimental
  Esomeprazole 40 mg Once Daily (initial phase)

  Drug: esomeprazole (Nexium®)

• Experimental
  Esomeprazole 20 mg Once Daily (Maintenance Phase)

  Drug: esomeprazole (Nexium®)

• Experimental
  Esomeprazole 20 mg on Demand (Maintenance Phase)

  Drug: esomeprazole (Nexium®)

• Experimental
  Antacid Treatment (Maintenance Phase)

  Drug: Xolaam®

Interventions

• Drugesomeprazole (Nexium®)

  This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

• DrugXolaam®

  This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Primary outcomes

1. Efficacy of Three Strategies of Long-term Treatment

   Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?

   Time frame: 16 weeks

Secondary outcomes

1. Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ).

   Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator. The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item.

   Time frame: 4 weeks

2. Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase

   No possibility to describe as only 2 patients took ASA

   Time frame: 4 weeks

3. Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)

   Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)

   Time frame: 4 to 16 weeks

4. Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment

   Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ \[8-10\] : possible anxiety-depression/ \>10 : anxiety-depression)

   Time frame: 16 weeks

5. Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study

   Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.

   Time frame: 12 weeks - maintenance treatment phase

6. Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire

   May be used to evaluate the severity of symptoms during the initial visit. Not done

   Time frame: Day 0

7. Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire

   May be used to offer patients a strategy of treatment during the initial phase and in the long term. Not done

   Time frame: Day 0

8. Score Abacuses Based on the Reflux Disease Questionnaire (RDQ)

   May be used to define the success of treatment. Not done

   Time frame: Week 4

Baseline characteristics