PMID- 21402616
OWN - NLM
STAT- MEDLINE
DCOM- 20111013
LR  - 20141120
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Linking)
VI  - 60
IP  - 9
DP  - 2011 Sep
TI  - A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients 
      with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: 
      a randomised placebo-controlled trial.
PG  - 1182-8
LID - 10.1136/gut.2010.235630 [doi]
AB  - OBJECTIVE: o evaluate the efficacy and tolerability of add-on treatment with 
      lesogaberan (AZD3355), a novel reflux inhibitor, in patients with persistent 
      gastro-oesophageal reflux disease (GORD) symptoms despite proton pump inhibitor 
      (PPI) therapy. METHODS: double-blind, placebo-controlled, randomised, 
      parallel-group, multicentre phase IIA study was carried out in outpatient 
      clinics. The study group comprised 244 adult patients with persistent GORD 
      symptoms (heartburn and/or regurgitation) of at least mild intensity and for 3 
      days of 7 days before enrolment, despite >/=6 weeks of continuous PPI therapy. 
      Patients received either lesogaberan (65 mg twice daily) or placebo in addition 
      to PPI therapy for a period of 4 weeks. Symptom intensity, based on the Reflux 
      Disease Questionnaire, was recorded twice daily. Treatment response (defined as 
      at most one 24 h period with heartburn or regurgitation of not more than mild 
      intensity during the last 7 days of treatment). Time to response, proportion of 
      symptom-free days and measures of tolerability were also analysed. RESULTS: total 
      of 232 (114 lesogaberan- and 118 placebo-treated patients) of the 244 randomised 
      patients were analysed for efficacy. Treatment with lesogaberan, compared with 
      placebo, resulted in a significantly larger proportion of responders to treatment 
      (16% vs 8% of patients; p=0.026) and cumulative proportion of responders over 
      time (log-rank p=0.0195). Lesogaberan was well tolerated: adverse events of 
      mostly mild to moderate intensity were reported in 45% of patients on lesogaberan 
      and in 37% on placebo. CONCLUSIONS: esogaberan add-on therapy to PPIs 
      significantly improved heartburn and regurgitation symptoms; however, the 
      proportion of responders was small. Clinical trial number NCT00394472.
FAU - Boeckxstaens, Guy E
AU  - Boeckxstaens GE
AD  - Department of Gastroenterology, University Hospital Leuven, Catholic University 
      of Leuven, Herestraat 49, 3000 Leuven, Belgium. uy.boeckxstaens@med.kuleuven.be
FAU - Beaumont, Hanneke
AU  - Beaumont H
FAU - Hatlebakk, Jan G
AU  - Hatlebakk JG
FAU - Silberg, Debra G
AU  - Silberg DG
FAU - Bjorck, Karin
AU  - Bjorck K
FAU - Karlsson, Maria
AU  - Karlsson M
FAU - Denison, Hans
AU  - Denison H
LA  - eng
SI  - ClinicalTrials.gov/NCT00394472
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110314
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
RN  - 0 (GABA-A Receptor Agonists)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Phosphinic Acids)
RN  - 0 (Propylamines)
RN  - 0 (Proton Pump Inhibitors)
RN  - 4D6Q6HGC7Z (lesogaberan)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Epidemiologic Methods
MH  - Female
MH  - GABA-A Receptor Agonists/administration & dosage/therapeutic use
MH  - Gastroesophageal Reflux/*drug therapy
MH  - Gastrointestinal Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphinic Acids/administration & dosage/adverse effects/*therapeutic use
MH  - Propylamines/administration & dosage/adverse effects/*therapeutic use
MH  - Proton Pump Inhibitors/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/03/16 06:00
MHDA- 2011/10/14 06:00
CRDT- 2011/03/16 06:00
PHST- 2011/03/16 06:00 [entrez]
PHST- 2011/03/16 06:00 [pubmed]
PHST- 2011/10/14 06:00 [medline]
AID - gut.2010.235630 [pii]
AID - 10.1136/gut.2010.235630 [doi]
PST - ppublish
SO  - Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.