Trial Outcomes & Findings for Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis (NCT NCT01146561)
NCT ID: NCT01146561
Last Updated: 2021-03-23
Results Overview
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).
TERMINATED
PHASE2
2 participants
Baseline, Week 1 to 8
2021-03-23
Participant Flow
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.
Participant milestones
| Measure |
Placebo
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Placebo
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=2 Participants
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Age, Customized
18 to 44 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
45 to 64 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1 to 8Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12, 16Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 1 to 8Population: 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.
Daily average worst chronic pancreatitis pain is assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 8Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 8, 16Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 8, 16Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12Population: 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.
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?".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weeks 4, 8, 16Population: 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.
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?".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 8, 16Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8, 16Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to Week 16Population: Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
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).
Outcome measures
| Measure |
Placebo
n=2 Participants
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Number of Participants With Injection Site Reaction
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Week 2, 4, 8, 16Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (pre-dose), Week 8, 16Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 112 days after the dose of study medication (up to 113 days)Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
Laboratory analysis included blood chemistry, hematology, urinalysis, pregnancy test, glycosylated hemoglobin levels (HbA1c levels) test and blood alcohol test.
Outcome measures
| Measure |
Placebo
n=2 Participants
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 16Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
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.
Outcome measures
| Measure |
Placebo
n=2 Participants
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1Population: ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.
Number of participants who received the single dose of placebo are reported.
Outcome measures
| Measure |
Placebo
n=2 Participants
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
Number of Participants With Subcutaneous Doses
|
2 Participants
|
Adverse Events
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=2 participants at risk
A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
|
|---|---|
|
General disorders
Injection site reaction
|
50.0%
1/2
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.
|
|
General disorders
Pain
|
50.0%
1/2
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.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2
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.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER