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Chronic PancreatitisPhase 2NCT01146561

Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

A Phase 2 study testing Tanezumab in people with Chronic Pancreatitis, run by Pfizer at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Tanezumab is effective in reducing the pain associated with chronic pancreatitis. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Chronic Pancreatitis
What is being tested?
Tanezumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
9 sitesUnited States
Study dates
13 Oct 2010to 22 Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Carolinas Digestive Health Associates

    Harrisburg, North Carolina, 28075

  • Carolinas Digestive Health Associates

    Harrisburg, North Carolina, 28705

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Gastroenterology Group-of Naples

    Naples, Florida, 34102-5449

  • UMPC Division of Radiology

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Palm Beach Gastroenterology

    Wellington, Florida, 33414

Other trials in United States

About this study

Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS

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

Read the detailed description

On 23 Dec 2010 the FDA imposed a clinical halt for anti-NGF compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-NGF compound of another company. All indications with the exception of Cancer Pain are affected resulting in termination of all studies in respective indications. Recruitment of Study A4091044 was stopped effective 27 Dec 2010. Two patients recruited so far did not receive further doses and were followed up for safety until LSLV on 22 Mar 2011.

Being tested
Tanezumab, Placebo
Medical subject headings
Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TanezumabBiological

    single administration of tanezumab 20 mg sub-cutaneously

  • PlaceboOther

    single administration of placebo to match tanezumab, sub-cutaneously

Study groups in NCT01146561
Study groupRoleWhat they receive
Tanezumab 20 mgExperimentalNot described
Receives: Biological: Tanezumab
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, Week 1 to 8

Secondary outcomes (16)

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

    Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

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

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

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

    Measured: Baseline, Week 1 to 8

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

    Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

    Measured: Week 8

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

    Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

    Measured: Week 8

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

    BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (question 5 consists of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure were scored by item, with lower scores indicated less pain or pain interference.

    Measured: Baseline, Week 8, 16

  6. Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and 16

    BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and question 5 consisted of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure was scored by item, with lower score indicated less pain or pain interference. The 7 items in question 5 were averaged to obtain pain interference index, range: 0 to 10; higher score=greater impairment.

    Measured: Baseline, Week 8, 16

  7. Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16

    Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".

    Measured: Baseline, Week 4, 8, 12

  8. Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis

    Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".

    Measured: Weeks 4, 8, 16

  9. Number of Participants With Anti Drug Antibody

    Measured: Baseline, Week 8, 16

  10. Neuropathy Impairment Score (NIS)

    NIS: 74-item questionnaire assesses muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

    Measured: Baseline and Weeks 2, 4, 8, 16

  11. Number of Participants With Injection Site Reaction

    Assessment of the injection site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

    Measured: Day 1 up to Week 16

  12. Plasma Tanezumab Levels

    Measured: Baseline (pre-dose), Week 2, 4, 8, 16

  13. Serum Nerve Growth Factor (NGF) Levels

    Measured: Baseline (pre-dose), Week 8, 16

  14. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

    Measured: Baseline up to 112 days after the dose of study medication (up to 113 days)

  15. Number of Participants With Clinically Significant Laboratory Abnormalities

    Laboratory analysis included blood chemistry, hematology, urinalysis, pregnancy test, glycosylated hemoglobin levels (HbA1c levels) test and blood alcohol test.

    Measured: Baseline up to Week 16

  16. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

    All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed for ECG abnormalities.

    Measured: Baseline up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2010 (estimated)
  2. Study start13 Oct 2010
  3. Primary completion22 Mar 2011
  4. Study completion22 Mar 2011

Why it stopped: See termination reason in detailed description.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01146561
Sponsor's protocol ID
A4091044
Other IDs
2010-019012-21, CHRONIC PANCREATITIS POC STUDY
Status last verified
Jan 2021
First submitted
24 May 2010
Last updated
23 Mar 2021
Data monitoring committee
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tanezumab in people with Chronic Pancreatitis, run by Pfizer at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8 (time frame: Baseline, Week 1 to 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01146561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.

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