Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Nimacimab in Patients With Diabetic Gastroparesis
NCT ID: NCT03900325
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
6 participants
INTERVENTIONAL
2019-08-01
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Nimacimab
2.5 mg/kg
Nimacimab
2.5 mg/kg
Placebo
0.9% sodium chloride
Placebo
0.9% sodium chloride
Interventions
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Nimacimab
2.5 mg/kg
Placebo
0.9% sodium chloride
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with diabetic gastroparesis, defined by:
1. 3 month past or current history of symptoms of gastroparesis (e.g. nausea, vomiting, bloating, abdominal pain, or feeling full earlier than normal after eating)
2. Screening or historical scintigraphy (3 years prior to screening) with \> 20% of solid contents retained at 4 hours.
* BMI \>= 20.0 and \< = 50.0 kg/m2
Exclusion Criteria
* Participants with any active prokinetic device are excluded, unless device is turned off for at least 7 days prior to any study scintigraphy exam and at least 7 days prior to the first dose through Day 15 of treatment.
* Participants who are currently participating in or have participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
* Participants with uncontrolled diabetes. Participants with controlled diabetes are allowed (insulin is allowed). HbA1c\>9.9% at screening are excluded.
18 Years
70 Years
ALL
No
Sponsors
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Bird Rock Bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Panax Clinical Research
Miami, Florida, United States
International Research Associates, LLC
Miami, Florida, United States
PRN of Kansas
Wichita, Kansas, United States
Mayo Clinic
Rochester, Minnesota, United States
ClinSearch
Chattanooga, Tennessee, United States
Countries
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Other Identifiers
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BRB-018-200DG
Identifier Type: -
Identifier Source: org_study_id
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