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

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Abdominal Pain Upper

Treatments: Drug: REGN475/SAR164877; Drug: Placebo (for REGN475/SAR164877)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001923

ACT11286

Details and patient eligibility

About

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.

Full description

The duration of the study period for each participant was up to 14 weeks, including a screening period up to 2 weeks, and 12-week follow-up after the injection.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe abdominal pain due to chronic pancreatitis of at least 6 months duration.

Exclusion criteria

• Mild pain on the Pain Intensity-Numeric Rating Scale [PI-NRS] at screening and randomization visits;
• Narcotic addiction;
• Recent pancreatic surgical or endoscopic intervention for chronic pancreatitis pain;
• Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

REGN475/SAR164877

Experimental group

Description:

REGN475/SAR164877, single injection, dose depending on the participant's body weight

Treatment:

Drug: REGN475/SAR164877

Placebo

Placebo Comparator group

Description:

Placebo (for REGN475/SAR164877), single injection

Treatment:

Drug: Placebo (for REGN475/SAR164877)