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The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive reflux disease (NERD) or healed erosive esophagitis (EE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLI5100 Low Dose | Experimental | Patients will take BLI5100 Low Dose once daily, orally, for up to 29 weeks. |
|
| BLI5100 High Dose | Experimental | Patients will take BLI5100 High Dose once daily, orally, for up to 29 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLI5100 | Drug | Patients will take BLI5100 once daily, orally, for up to 29 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment-emergent adverse events | 31 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
History of alcoholism, or substance abuse/addiction in the year before enrollment in the BLI5100-301 and BLI5100-302 studies;
A diagnosis of manic-depression, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other psychological disorder is exclusionary, unless the patient is asymptomatic and well-controlled. Stable treatment, including non-medical therapy, is preferred, but minor adjustments can be made and should be consulted with the Medical Monitor;
Current use of antipsychotics, antidepressants, anxiolytics, or prescription sleeping medications, with the exception of a stable dose for the duration of the BLI5100-301 and BLI5100-302 studies;
Requirement of persistent (>3 times per week for >30 days) use of non-steroidal anti-inflammatory drugs (NSAIDs) during the course of the study;
o Note: Low-dose (≤100 mg/day) aspirin is allowed provided that it has been used for prophylaxis prior to study participation.
If a female, is pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after the last dose of study drug;
Abnormal laboratory results with clinical relevance at Screening as follows:
Abnormal ECG of clinical significance;
Involvement in another clinical study (other than BLI5100-301 and BLI5100-302 studies) within 4 weeks of initiation of study drug;
Any other clinically relevant condition that would confound study endpoints or adversely affect patient compliance with the study procedures in the medical judgment of the Investigator or Medical Monitor based on previous medical history or findings on Screening assessments.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site 24 | Huntsville | Alabama | 35801 | United States | ||
| Research Site 62 |
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| Phoenix |
| Arizona |
| 85018 |
| United States |
| Research Site 27 | Tucson | Arizona | 85712 | United States |
| Research Site 87 | Little Rock | Arkansas | 72211 | United States |
| Research Site 117 | North Little Rock | Arkansas | 72117 | United States |
| Research Site 94 | Chula Vista | California | 91910 | United States |
| Research Site 10 | Huntington Park | California | 90255 | United States |
| Research Site 55 | La Mesa | California | 91942 | United States |
| Research Site 72 | Los Angeles | California | 90017 | United States |
| Research Site 54 | Los Angeles | California | 90057 | United States |
| Research Site 13 | Santa Ana | California | 92704 | United States |
| Research Site 41 | Santa Maria | California | 93458 | United States |
| Research Site 108 | Cooper City | Florida | 33024 | United States |
| Research Site 91 | Doral | Florida | 33172 | United States |
| Research Site 78 | Homestead | Florida | 33030 | United States |
| Research Site 23 | Maitland | Florida | 32751 | United States |
| Research Site 38 | Miami | Florida | 33134 | United States |
| Research Site 43 | Miami | Florida | 33136 | United States |
| Research Site 67 | Miami | Florida | 33155 | United States |
| Research Site 92 | Miami | Florida | 33173 | United States |
| Research Site 71 | Miami | Florida | 33186 | United States |
| Research Site 42 | Miami Lakes | Florida | 33014 | United States |
| Research Site 17 | New Port Richey | Florida | 34653 | United States |
| Research Site 90 | Ocoee | Florida | 34761 | United States |
| Research Site 05 | Palmetto Bay | Florida | 33157 | United States |
| Research Site 11 | Sunrise | Florida | 33351 | United States |
| Research Site 46 | Viera | Florida | 32940 | United States |
| Research Site 59 | Sandy Springs | Georgia | 30328 | United States |
| Research Site 01 | Gurnee | Illinois | 60031 | United States |
| Research Site 02 | Oak Lawn | Illinois | 60453 | United States |
| Research Site 45 | Houma | Louisiana | 70363 | United States |
| Research Site 12 | Marrero | Louisiana | 70072 | United States |
| Research Site 48 | Metairie | Louisiana | 70006 | United States |
| Research Site 34 | New Orleans | Louisiana | 70127 | United States |
| Research Site 111 | Chesterfield | Missouri | 63005 | United States |
| Research Site 06 | Las Vegas | Nevada | 89106 | United States |
| Research Site 64 | Reno | Nevada | 89511 | United States |
| Research Site 35 | Brooklyn | New York | 11235 | United States |
| Research Site 07 | Great Neck | New York | 11023 | United States |
| Research Site 28 | Hartsdale | New York | 10530 | United States |
| Research Site 49 | New York | New York | 10033 | United States |
| Research Site 40 | Rochester | New York | 14609 | United States |
| Research Site 75 | Fayetteville | North Carolina | 28304 | United States |
| Research Site 20 | Columbus | Ohio | 43213 | United States |
| Research Site 88 | Columbus | Ohio | 43215 | United States |
| Research Site 109 | Mentor | Ohio | 44060 | United States |
| Research Site 110 | Westlake | Ohio | 44145 | United States |
| Research Site 60 | Nashville | Tennessee | 37203 | United States |
| Research Site 103 | Nashville | Tennessee | 37211 | United States |
| Research Site 100 | Bellaire | Texas | 77401 | United States |
| Research Site 98 | Dallas | Texas | 75230 | United States |
| Research Site 99 | Forney | Texas | 75126 | United States |
| Research Site 29 | Lewisville | Texas | 75057 | United States |
| Research Site 32 | Pearland | Texas | 77584 | United States |
| Research Site 30 | Red Oak | Texas | 75154 | United States |
| Research Site 22 | San Antonio | Texas | 78209 | United States |
| Research Site 26 | San Antonio | Texas | 78229 | United States |
| Research Site 21 | San Antonio | Texas | 78249 | United States |
| Research Site 65 | Sandy City | Utah | 84092 | United States |
| Research Site 16 | South Ogden | Utah | 84405 | United States |
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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