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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of SPI-8811 Oral Solution in Patients With Non-erosive Reflux Disease (NERD) Refractory to Proton Pump Inhibitors

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of SPI-8811 Oral Solution in Patients With Non-erosive Reflux Disease (NERD) Refractory to Proton Pump Inhibitors

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222711
Enrollment
Unknown
Registered
2014-12-26
Start date
2014-12-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Non-erosive Reflux Disease

Interventions

investigational material(s) Generic name etc : SPI-8811 Oral Solution INN of investigational material : cobiprostone Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration f
Week 1 to 4: 36 mcg/day, Week 5 to 8: 72 mcg/day

Sponsors

Sucampo Pharma, LLC.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient has non-erosive reflux disease and insufficient response to the standard dose of a PPI. Patient who has no mucosal change by upper gastrointestinal tract endoscopy on the day before the study treatment.

Exclusion criteria

Exclusion criteria:

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026