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Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain

NCT01001923 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-05-27

No results posted yet for this study

Summary

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with chronic pancreatitis.

Secondary objectives were:

* to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic pancreatitis pain;
* to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of REGN475/SAR164877 in this population;
* to measure the change in the total daily dose of rescue medications required.

Conditions

  • Abdominal Pain Upper

Interventions

DRUG

REGN475/SAR164877

Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

DRUG

Placebo (for REGN475/SAR164877)

Pharmaceutical form: solution Route of administration: intravenous infusion over 30 minutes

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001923 on ClinicalTrials.gov