NCT02025049

Brief Summary

Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe inflammation of the pancreas, can mitigate the development of processes that can lead to serious complications of this disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 23, 2015

Status Verified

December 1, 2013

Enrollment Period

1.4 years

First QC Date

December 25, 2013

Last Update Submit

June 22, 2015

Conditions

Pancreatitis

Keywords

pancreatitis

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein serum concentration

    6 days

Study Arms (2)

DP-b99

EXPERIMENTAL

Intravenous DP-b99, 1.0 mg/kg twice daily for 2 consecutive days

Drug: DP-b99

Placebo

PLACEBO COMPARATOR

Intravenous placebo (mannitol based, DP-b99 look-alike) twice daily for 2 consecutive days

Drug: Placebo

Interventions

DP-b99DRUG

DP-b99 is a lipophilic analog of the divalent metal ion chelator O,O'-Bis(2-aminophenyl) ethyleneglycol-N,N,N',N'-tetraacetic acid (BAPTA)

Also known as: Chemical name: 1,2-Bis(2-aminophenoxy)ethane- N,N,N'N'-tetraacetic acid, N,N'-di(octyloxyethyl ester), N,N'-disodium salt, CAS Number: 222315-66-4
DP-b99
PlaceboDRUG

mannitol-based DP-b99 look-alike

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject.
  • Age 18 years or higher.
  • First in a lifetime episode of acute pancreatitis.
  • Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis
  • History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening).
  • BISAP score of 3 or higher
  • Study treatment initiation is possible within 48 h of symptom onset
  • Ability to provide informed consent

You may not qualify if:

  • Drug-induced, viral, hereditary or post-ERCP pancreatitis.
  • Recurrent episode of pancreatitis.
  • CT evidence of pancreatic necrosis at study entry.
  • Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ.
  • Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis).
  • High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week.
  • Class II or greater New York Heart Association heart failure.
  • Oxygen-dependent chronic obstructive pulmonary disease (COPD).
  • Cirrhosis of the liver.
  • Severe anemia (hemoglobin less than 8 g/dL).
  • Hematocrit below 35 % or above 45 % at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset).
  • Serum alanine aminotransferase above 250 IU/L at study entry.
  • Clinical suspicion of ascending cholangitis at study entry.
  • Active gastrointestinal bleeding.
  • Current malignancy not in remission (other than basal cell carcinoma of skin).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University Hospital Brno, Gastroenterology Clinic

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

DP-b99

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Gilad Rosenberg, MD

    D-Pharm Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2013

First Posted

December 31, 2013

Study Start

December 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 23, 2015

Record last verified: 2013-12

Locations

CZ(1)