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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019012-21 | EudraCT Number | ||
| CHRONIC PANCREATITIS POC STUDY | Other Identifier | Alias Study Number |
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See termination reason in detailed description.
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Tanezumab is effective in reducing the pain associated with chronic pancreatitis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tanezumab 20 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tanezumab | Biological | single administration of tanezumab 20 mg sub-cutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Week 1, 2, 4, 6, 8, 12, 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Subcutaneous Doses | Number of participants who received the single dose of placebo are reported. | Day 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Group-of Naples | Naples | Florida | 34102-5449 | United States | ||
| Palm Beach Gastroenterology |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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Due to the United States Food and Drug Administration (FDA) clinical hold, the study was prematurely terminated and no participants were enrolled in planned reporting arm tanezumab 20 milligram (mg) treatment and hence tanezumab 20 mg could not be administrated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 1 to 8 |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C549319 | tanezumab |
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| Placebo |
| Other |
single administration of placebo to match tanezumab, sub-cutaneously |
|
| 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). |
| 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 | 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). | Week 8 |
| 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). | Week 8 |
| 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. | Baseline, Week 8, 16 |
| 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. | Baseline, Week 8, 16 |
| 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?". | Baseline, Week 4, 8, 12 |
| 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?". | Weeks 4, 8, 16 |
| Number of Participants With Anti Drug Antibody | Baseline, Week 8, 16 |
| 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. | Baseline and Weeks 2, 4, 8, 16 |
| 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). | Day 1 up to Week 16 |
| Plasma Tanezumab Levels | Baseline (pre-dose), Week 2, 4, 8, 16 |
| Serum Nerve Growth Factor (NGF) Levels | Baseline (pre-dose), Week 8, 16 |
| 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. | Baseline up to 112 days after the dose of study medication (up to 113 days) |
| 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. | Baseline up to Week 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. | Baseline up to Week 16 |
| Wellington |
| Florida |
| 33414 |
| United States |
| Digestive Health Specialists | Tupelo | Mississippi | 38801 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Carolinas Digestive Health Associates | Harrisburg | North Carolina | 28075 | United States |
| Carolinas Digestive Health Associates | Harrisburg | North Carolina | 28705 | United States |
| UMPC Division of Radiology | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
| Secondary | 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). | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 1, 2, 4, 6, 8, 12, 16 |
|
|
| Secondary | 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). | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 1 to 8 |
|
|
| Secondary | 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). | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Week 8 |
|
|
| Secondary | 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). | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Week 8 |
|
|
| Secondary | 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. | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 8, 16 |
|
|
| Secondary | 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. | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 8, 16 |
|
|
| Secondary | 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?". | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 4, 8, 12 |
|
|
| Secondary | 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?". | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Weeks 4, 8, 16 |
|
|
| Secondary | Number of Participants With Anti Drug Antibody | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline, Week 8, 16 |
|
|
| Secondary | 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. | No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline and Weeks 2, 4, 8, 16 |
|
|
| Secondary | 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). | Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. | Posted | Count of Participants | Participants | Day 1 up to Week 16 |
|
|
|
| Secondary | Plasma Tanezumab Levels | No pharmacokinetic analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline (pre-dose), Week 2, 4, 8, 16 |
|
|
| Secondary | Serum Nerve Growth Factor (NGF) Levels | No analysis was performed for this outcome measure as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold. | Posted | Baseline (pre-dose), Week 8, 16 |
|
|
| Secondary | 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. | ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. | Posted | Count of Participants | Participants | Baseline up to 112 days after the dose of study medication (up to 113 days) |
|
|
|
| Secondary | 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. | ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
|
|
|
| Secondary | 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. | ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. | Posted | Count of Participants | Participants | Baseline up to Week 16 |
|
|
|
| Other Pre-specified | Number of Participants With Subcutaneous Doses | Number of participants who received the single dose of placebo are reported. | ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |