Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

NCT01146561 | Terminated Phase 2 Results

• 3 other identifiers: A40910442010-019012-21CHRONIC PANCREATITIS POC STUDY
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 9

Brief Summary

Tanezumab is effective in reducing the pain associated with chronic pancreatitis.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8

  Daily average chronic pancreatitis pain is assessed with an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

  Baseline, Week 1 to 8

Secondary Outcomes (16)

• Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16

  Baseline, Week 1, 2, 4, 6, 8, 12, 16

• Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period

  Baseline, Week 1 to 8

• Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score

  Week 8

• Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score

  Week 8

• Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16

  Baseline, Week 8, 16

Other Outcomes (1)

• Number of Participants With Subcutaneous Doses

  Day 1

Study Arms (2)

Tanezumab 20 mg

EXPERIMENTAL

Biological: Tanezumab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Tanezumab BIOLOGICAL

single administration of tanezumab 20 mg sub-cutaneously

Tanezumab 20 mg

Placebo OTHER

single administration of placebo to match tanezumab, sub-cutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female
• Written informed consent
• Diagnosis of chronic pancreatitis based on imaging studies
• Persistent abdominal pain due to chronic pancreatitis
• Qualifying pain score during the pre-treatment period
• Willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control

You may not qualify if:

• Pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study
• Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction
• Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months
• History of alcoholism (within 1 year of screening) or concurrent alcohol abuse
• History of cancer in the past years
• Significant cardiac disease within 6 months
• History, diagnosis or signs and symptoms of significant neurologic disease
• Disqualifying laboratory values including Hepatitis B or C, HIV and drug test
• Other medical condition that may interfere with study endpoints or safety of the patient as determined by the Investigator
• Known history of rheumatoid arthritis
• Avascular necrosis of the bone
• History of trauma to a major joint Evidence of osteoarthritis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Gastroenterology Group-of Naples

Naples, Florida, 34102-5449, United States

Location

Palm Beach Gastroenterology

Wellington, Florida, 33414, United States

Location

Digestive Health Specialists

Tupelo, Mississippi, 38801, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Carolinas Digestive Health Associates

Harrisburg, North Carolina, 28075, United States

Location

Carolinas Digestive Health Associates

Harrisburg, North Carolina, 28705, United States

Location

UMPC Division of Radiology

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

tanezumab

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to FDA clinical hold, the study was prematurely terminated with only 2 participants were enrolled and randomized to placebo treatment and hence, efficacy and pharmacokinetic analysis was not performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: May 24, 2010
• First Posted: June 17, 2010
• Study Start: October 13, 2010
• Primary Completion: March 22, 2011
• Study Completion: March 22, 2011
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (9)