Status and phase
Conditions
Treatments
About
The purpose of this study is to determine the safety and efficacy of NI-03.
Full description
The primary objective of the Single-Dose Phase is to assess the pharmacokinetics (PK) and safety of single doses of NI-03 when administered at doses of 100 mg, 200 mg or 300 mg to subjects with chronic pancreatitis.
The primary objective of the Double-Blind Phase of the study is to determine the efficacy, PK and safety of three doses of NI-03 (100 mg, 200 mg and 300 mg) as compared to placebo when administered three times daily (TID) for 28 consecutive days in subjects with chronic pancreatitis.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
To be eligible to participate in this study, subjects must meet all of the following criteria at Screening:
Exclusion criteria
To be eligible to participate in this study, subjects must not meet any of the following criteria:
Primary purpose
Allocation
Interventional model
Masking
264 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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