Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
NCT03031938
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Cancer Pain, Recurrent Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0-2
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study.
- The infant's mother (who was the tanezumab clinical study participant) must review, agree and sign an informed consent document explaining the details of the perinatal and post natal follow up. Where local regulations mandate, the male parent would also review and sign the informed consent.
- Parents or legal guardian must be willing and able to comply with scheduled visits and study procedures.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- There are no exclusion criteria for participating in this study.
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Osteoarthritis, Cancer Pain, Recurrent Low Back PainProtocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
NCT03031938
- Sarasota, Florida
- Sarasota, Florida
- Tampa, Florida
- Lafayette, Indiana
- Lafayette, Indiana
- Los Angeles, California
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description | A4091065 is a long term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063 | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Other | ||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Investigational medical product (IMP) administered in parent study
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study | ||||||
| Study Arms ICMJE | Cohort 1
Long term observational study of subjects from tanezumab parent study Intervention: Drug: Investigational medical product (IMP) administered in parent study | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 4 | ||||||
| Original Estimated Enrollment ICMJE | 10 | ||||||
| Actual Study Completion Date ICMJE | June 4, 2020 | ||||||
| Actual Primary Completion Date | June 4, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 2 Months (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03031938 | ||||||
| Other Study ID Numbers ICMJE | A4091065 2013-002548-10 ( EudraCT Number ) INFANT SAFETY FOLLOW-UP #2 ( Other Identifier: Alias Study Number ) NEONATAL MONITORING STUDY #2 ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Eli Lilly and Company | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | August 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||