Trial Information

Summary: Nocturnal GERD

Phase 3, double-blind, placebo-controlled study to evaluate the efficacy of the study drug compared to placebo. The study consists of 4 weeks and 21 day screening period with 3 office visits. You will be compensated for your time and travel upon completion of study.

Patient Inclusion Criteria:

  • Male or female age 18-65
  • History of nocturnal heartburn/GERD associated with sleep disturbance (at least 3 out of 7 nights)
  • History of EE diagnosed more than 6 months ago that was responsive to therapy

Patient Exclusion Criteria:

  • Allergy to any PPI or Gelusil
  • Endoscopic finding of EE during screening endoscopy
  • Active gastric ulcer within 30 days of screening
  • History of GI Bleed within 6 months of screening
  • History of esophageal abnormality (Barrett's esophagus, stricture/narrowing ect.)
  • Any other conditions that may cause problems sleeping (sleep apnea,seizure disorder, RLS, insomnia, narcolepsy etc.)
  • History of Cancer within previous 5 years (except BCC)
  • Shift workers

Contact:

Renstar Medical Research
104 SE 1st Ave, Suite B
Ocala, FL 34471
Telephone: 352-629-5800 or 877-629-5800
Email:

Profile Page: Renstar Medical Research, Ocala, FL

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: March 31, 2008 at 2:36:32 PM


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