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?The effect of acute and chronic administration of the CCK1 receptor antagonist Dexloxiglumide (CR2017) on 24-h pH metry, LES motor and symptoms? pattern, in patients with gastroesophageal reflux disease (GERD). A randomized, double-blind, placebo controlled study? - ND

?The effect of acute and chronic administration of the CCK1 receptor antagonist Dexloxiglumide (CR2017) on 24-h pH metry, LES motor and symptoms? pattern, in patients with gastroesophageal reflux disease (GERD). A randomized, double-blind, placebo controlled study? - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003478-25-IT
Enrollment
Unknown
Registered
2009-03-06
Start date
2008-02-25
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesaphageal reflux disease (GERD) MedDRA version: 9.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease

Interventions

Product Name: Dexloxiglumide Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DEXLOXIGLUMIDE CAS Number: 119818-90-2 Current Sponsor code: CR 2017 Concentration unit: mg milligram(s) Conce

Sponsors

ROTTAPHARM / ROTTA RESEARCH LABORATORIUM
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - males or female - age >=18 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - hiatal hernia - abdominal surgery - pregnant or breast-feeding females - significant diseases - use of prohibited medication (among which, H2 blockers and antiacids)

Design outcomes

Primary

MeasureTime frame
Secondary Objective: safety and efficacy of dexloxiglumide after acute (1 day) and chronic (4 weeks) treatment on pH reduction of the esophagus and symptoms improvement in an adult population of both sexes suffering from GERD;Primary end point(s): reduction of number of TLESRs measured during a 24h pH-manometry;Main Objective: efficacy of dexloxiglumide after acute (1 day) and chronic (4 weeks) treatment on the improvement of LES motility in an adult population of both sexes suffering from GERD—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026