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

Primary Purpose

Abdominal Pain Upper

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

REGN475/SAR164877

Placebo (for REGN475/SAR164877)

About this trial

This is an interventional treatment trial for Abdominal Pain Upper

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REGN475/SAR164877

Placebo

Arm Description

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

Placebo (for REGN475/SAR164877), single injection

Outcomes

Primary Outcome Measures

Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS)

The baseline value was defined as the average of PI-NRS values obtained at screening and at randomization visit. The Week 4 value was defined as the average of PI-NRS values obtained daily through e-Diary assessments during Week 4.

Secondary Outcome Measures

Mean change from baseline in pain intensity as assessed by PI-NRS

Percentage of pain-free days (score "0" pain on PI-NRS)

Percentage of days with rescue analgesia use

Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score

Patient Global Impression of Change [PGIC] score

Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity

Pharmacokinetic: REGN475/SAR164877 serum concentration

Full Information

NCT ID

NCT01001923

First Posted

October 26, 2009

Last Updated

May 20, 2013

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01001923

Brief Title

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

Official Title

Randomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Terminated

Why Stopped

Business decision due to low subject recruitment and enrollment

Study Start Date

December 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Pain Upper

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REGN475/SAR164877

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (for REGN475/SAR164877), single injection

Intervention Type

Drug

Intervention Name(s)

REGN475/SAR164877

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo (for REGN475/SAR164877)

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean change from baseline in pain intensity as assessed by Pain Intensity Numeric Rating Scale (PI-NRS)

Description

Time Frame

baseline and 4 weeks after injection

Secondary Outcome Measure Information:

Title

Mean change from baseline in pain intensity as assessed by PI-NRS

Time Frame

baseline and every other weeks up to 12 weeks after injection

Title

Percentage of pain-free days (score "0" pain on PI-NRS)

Time Frame

12 weeks

Title

Percentage of days with rescue analgesia use

Time Frame

12 weeks

Title

Change from baseline in Short Form-12 Item Quality of Life Questionnaire [SF-12] score

Time Frame

baseline and 4, 8, 12 weeks

Title

Patient Global Impression of Change [PGIC] score

Time Frame

4, 8 and 12 weeks

Title

Percentage of participants with at least 30% and 50% reduction from baseline in pain intensity

Time Frame

up to 12 weeks after injection

Title

Pharmacokinetic: REGN475/SAR164877 serum concentration

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Investigational Site Number 840024

City

Arcadia

State/Province

California

ZIP/Postal Code

91007

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840011

City

Bell Gardens

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840003

City

Monterey

State/Province

California

ZIP/Postal Code

93940

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840048

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840034

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840031

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840029

City

St. Petersburg

State/Province

Florida

ZIP/Postal Code

33703

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840017

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840013

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840030

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840023

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840052

City

Winston Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840005

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840043

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840053

City

Desoto

State/Province

Texas

ZIP/Postal Code

75115

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840050

City

Southlake

State/Province

Texas

ZIP/Postal Code

76092

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840040

City

East Sandy

State/Province

Utah

ZIP/Postal Code

84094

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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

Abdominal Pain Upper

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial