Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Nervous System Diseases

Recurrence

Osteoarthritis

Cancer Pain

Back Pain

Low Back Pain

Pain

Neurologic Manifestations

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Naproxen

Diclofenac

Celecoxib

Tanezumab

Long term observational study of subjects from tanezumab parent study

IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study

Investigational medical product (IMP) administered in parent study

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A4091065 is a multicenter, prospective, cohort study with enhance physical an neurodevelopmental surveillance to characterize the outcomes related to the development of infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or comparator via maternal exposure or in utero in any tanezumb study.

A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063

Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

A PROTOCOL TO MONITOR FROM BIRTH TO AGE 15 MONTHS THE NEUROLOGICAL DEVELOPMENT OF INFANTS WITH EXPOSURE IN-UTERO IN TANEZUMAB CLINICAL STUDIES AT ALL INVESTIGATIONAL SITES

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.

Occipital-frontal head circumference of participants in centimeter (cm) was reported.

Occipital-frontal head circumference of participants in cm was reported.

Body length of participants in cm was reported.

Body weight of participants in kilogram (kg) was reported.

Body weight of participants in kg was reported.

Systolic and diastolic blood pressure of participants in millimeter of mercury (mmHg) was reported.

Systolic and diastolic blood pressure of participants in mmHg was reported.

Pulse rate of participants in beats per minute was reported.

Temperature of participants in degree Celsius was reported.

Respiratory rate of participants in breaths per minute was reported.

Neurologic examination evaluated all cranial nerves except I (smell), IX (taste) and XI (shoulder shrug). Motor examination included evaluation of muscle tone, bulk and movement. Sensory examination included test of temperature and superficial pain (homologous dermatomes using cold tuning fork, neurological examination pin) and deep pain by pressure on achilles tendon. Reflex evaluation included biceps, brachioradialis, patellar, and achilles tendons. Evaluation for persistence of developmental reflexes including Moro reflex, palmar and planter grasp, and tonic neck response was evaluated. Autonomic nervous system evaluation included examination of pupillary reaction, heart rate changes in response to activity, and inquiring about abnormal sweating. Abnormality was determined by the assessor.

BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance.

BINS: a validated instrument designed specifically for a high-risk infant population. It consisted of 11-13 items for different age levels (11 items for participants aged from 3-4 months, 11-15 months, 16-20 months; 13 items for participants aged from 5-6 months, 7-10 months, 21-24 months) to assess cognitive, social, language, gross, and fine motor skills. Each item was scored on a range 0 = non-optimal performance to 1 = optimal performance; BINS total score was sum of scores of each item and it ranged for 11 items from 0 (non-optimal performance) to 11 (optimum performance) and for 13 items from 0 (non-optimal performance) to 13 (optimum performance), higher score indicated better performance. Data collected at age of 26 months used 24 months' age items.

REEL-3, was designed to identify infants and toddlers who had language impairments or who had other disabilities that affect language development. Caregiver answered interview questionnaire by pediatrician, pediatric neurologist or clinical psychologist for receptive language and expressive language subtests. Each of these 2 sub tests had 66 questions with answer of 'yes = 1' or 'no = 0'. Sum of receptive and expressive language subtests answers was used to calculate REEL-3 language ability total score, with following ranges: \<70 (very poor), 70-79 (poor), 80-89 (below average), 90-110 (average), 111-120 (above average), 121-130 (superior), and \>130 (very superior). Higher scores indicated better language ability.

Eli Lilly and Company

Pfizer

Same event may appear as both adverse event (AE) and serious adverse event (SAE). An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE.

Infants in this reporting arm were those who had potential maternal exposure to tanezumab.

Maternal Exposure to Tanezumab

Infants in this reporting arm were those who had potential maternal exposure to comparator tramadol.

Maternal Exposure to Tramadol

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race

Race/Ethnicity, Customized

Safety population included all participants who were enrolled into the study.

Pfizer ClinicalTrials.gov Call Center

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Occipital-frontal Head Circumference at 8 Months of Participant's Age

Occipital-frontal Head Circumference at 15 Months of Participant's Age

Occipital-frontal Head Circumference During 0 to Less Than or Equal to (<=) 3 Months of Participant's Age

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for reporting arm "Maternal Exposure to Tramadol" had a visit within this window period, hence, for this reporting group no data was collected and reported.

Occipital-frontal Head Circumference During Greater Than (>) 3 to <=6 Months of Participant's Age

Occipital-frontal Head Circumference During >6 to <=9 Months of Participant's Age

Occipital-frontal Head Circumference During >15 to <=18 Months of Participant's Age

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period \>21 to \<=24 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Occipital-frontal Head Circumference During >21 to <=24 Months of Participant's Age

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. No participant visited the site for window period \>24 to \<=30 months for reporting arm "Maternal Exposure to Tramadol". Hence, for this reporting group no data was collected and reported.

Occipital-frontal Head Circumference During >24 to <=30 Months of Participant's Age

Body Length During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Body Length at 8 Months of Participant's Age

Body Length at 15 Months of Participant's Age

Body Length During 0 to <=3 Months of Participant's Age

Body Length During >3 to <=6 Months of Participant's Age

Body Length During >6 to <=9 Months of Participant's Age

Body Length During >15 to <=18 Months of Participant's Age

Body Length During >21 to <=24 Months of Participant's Age

Body Length During >24 to <=30 Months of Participant's Age

Body Weight During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Body Weight at 8 Months of Participant's Age

Body Weight at 15 Months of Participant's Age

Body Weight During 0 to <=3 Months of Participant's Age

Body Weight During >3 to <=6 Months of Participant's Age

Body Weight During >6 to <=9 Months of Participant's Age

Body Weight During >15 to <=18 Months of Participant's Age

Body Weight During >21 to <=24 Months of Participant's Age

Body Weight During >24 to <=30 Months of Participant's Age

Systolic Blood Pressure

Diastolic Blood Pressure

Systolic and Diastolic Blood Pressure During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Systolic and Diastolic Blood Pressure at 8 Months of Participant's Age

Systolic and Diastolic Blood Pressure at 15 Months of Participant's Age

Systolic and Diastolic Blood Pressure During 0 to <=3 Months of Participant's Age

Safety population analyzed. Window period 3 to 6 months was not protocol defined but was an additional window to report data for participants whose initial visit was outside of the protocol defined window of 0-2 months. No participant for "Maternal Exposure to Tramadol" had a visit within this window period; for "Maternal Exposure to Tanezumab" site missed to take participants' measurement. Thus, no data was collected and reported for both reporting arms.

Systolic and Diastolic Blood Pressure During >3 to <=6 Months of Participant's Age

Systolic and Diastolic Blood Pressure During >6 to <=9 Months of Participant's Age

Systolic and Diastolic Blood Pressure During >15 to <=18 Months of Participant's Age

Systolic and Diastolic Blood Pressure During >21 to <=24 Months of Participant's Age

Systolic and Diastolic Blood Pressure During >24 to <=30 Months of Participant's Age

Safety population included all participants who were enrolled into the study. Here, "Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.

Pulse Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Pulse Rate at 8 Months of Participant's Age

Pulse Rate at 15 Months of Participant's Age

Pulse Rate During 0 to <=3 Months of Participant's Age

Pulse Rate During >3 to <=6 Months of Participant's Age

Pulse Rate During >6 to <=9 Months of Participant's Age

Pulse Rate During >15 to <=18 Months of Participant's Age

Pulse Rate During >21 to <=24 Months of Participant's Age

Pulse Rate During >24 to <=30 Months of Participant's Age

Temperature During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Temperature at 8 Months of Participant's Age

Temperature at 15 Months of Participant's Age

Temperature During 0 to <=3 Months of Participant's Age

Temperature During >3 to <=6 Months of Participant's Age

Temperature During >6 to <=9 Months of Participant's Age

Temperature During >15 to <=18 Months of Participant's Age

Temperature During >21 to <=24 Months of Participant's Age

Temperature During >24 to <=30 Months of Participant's Age

Safety population included all participants who were enrolled into the study. Here "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Respiratory Rate During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Respiratory Rate at 8 Months of Participant's Age

Respiratory Rate at 15 Months of Participant's Age

Respiratory Rate During 0 to <=3 Months of Participant's Age

Respiratory Rate During >3 to <=6 Months of Participant's Age

Respiratory Rate During >6 to <=9 Months of Participant's Age

Respiratory Rate During >15 to <=18 Months of Participant's Age

Respiratory Rate During >21 to <=24 Months of Participant's Age

Respiratory Rate During >24 to <=30 Months of Participant's Age

Number of Participants With Abnormal Neurological Examination Findings During 0 to Less Than or Equal to (<=) 2 Months of Participant's Age

Number of Participants With Abnormal Neurological Examination Findings at 8 Months of Participant's Age

Number of Participants With Abnormal Neurological Examination Findings at 15 Months of Participant's Age

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for neurological examination. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm.

Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 1 (Month 20 of Participant's Age)

Number of Participants With Abnormal Neurological Examination Findings at Follow-up Visit 2 (Month 26 of Participant's Age)

Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 8 of Participant's Age

Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Month 15 of Participant's Age

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for BINS assessment. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm.

Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 1 (Month 20 of Participant's Age)

Bayley Infant Neurodevelopmental Screener (BINS) Total Score at Follow-up Visit 2 (Month 26 of Participant's Age)

Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 8 of Participant's Age

Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Month 15 of Participant's Age

Safety population analyzed. "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure. Protocol defined mandatory visits were till age of 15 months. Investigator upon previous assessment suggested only 1 participant of reporting arm "Maternal Exposure to Tanezumab" to have follow up visit for REEL-3 assessment. No participant of reporting arm "Maternal Exposure to Tramadol" was suggested for follow up visit, thus no data reported for this arm

Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 1 (Month 20 of Participant's Age)

Bzoch-League Receptive Expressive Emergent Language Test 3rd Edition (REEL-3) Language Ability Score at Follow-up Visit 2 (Month 26 of Participant's Age)

Spots Global Cancer Trial Database for Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies

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