JCP Study of Investigation of Patient Background Characte... | NCT01332474

Studies
JCP Study of Investigation of Patient Background Characteristics

NCT01332474

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 7, 2017Actual

Enrollment

326Actual

Phase

Not provided

Conditions

Spasticity, Post-Stroke

Interventions

BOTOX

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Apr 7, 2011

First Submission Date that Met QC Criteria

Apr 7, 2011

First Posted Date

Apr 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2017

Last Update Posted Date

Jun 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To collect the background characteristics of juvenile cerebral palsy patients aged 2-year or older prescribed BOTOX for the treatment of equines foot due to lower limb spasticity, compare them with those of patients whose deaths or adverse drug reactions (ADRs) related to the possible spread of toxin are reported through the spontaneous ADR reporting system, and discuss potential risk factors for such ADRs.

Detailed Description

In each of prospective medical institutions (where BOTOX is expected to be prescribed annually to at least 10 juvenile cerebral palsy patients aged 2-year or older), the Medical Representative will explain the objectives, subjects and methods of the investigation to the prospective investigator (i.e., a physician who will prescribe BOTOX and can comply with the protocol of the investigation) and ask for his/her participation in the investigation.
When the physician agrees to participate in the investigation, a written agreement will be concluded between GSK and the head (e.g. director) of the medical institution prior to the start of the investigation.
After the completion of the investigation period, the physician will complete the case report form (CRF) for the patients prescribed BOTOX by him/her during the investigation period. The information of the patients who developed ADRs will be collected separately through the spontaneous ADR reporting system on a daily basis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

326Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JCP		treatment of Equinus Foot due to Lower Limb Spasticity in Juvenile Cerebral Palsy Patients Aged 2-year or Older	Drug: BOTOX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BOTOX	Drug	BOTOX	JCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
compare JCP patients with those of patients whose deaths or adverse drug reactions (ADRs) related to the possible spread of toxin are reported through the spontaneous ADR reporting system.		2010/5/1-2010/8/31

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Background factors:

The following background characteristics will be compared between the patients collected during the investigation and the patients whose deaths or ADRs related to the possible spread of toxin are reported through the spontaneous ADR reporting system, to discuss the potential risk factors for death or spread of toxin:

severity of indication (cerebral palsy) prior to use of BOTOX
Medical history/concurrent medical conditions (e.g., dysphagia, seizure, pulmonary disorder, neuromuscular disorder, and cardiac disorder, and others) ; Yes/No, and if yes, specify the diseases
Use of concomitant drugs and non-drug therapies
Dose per kg body weight
Dose per injection site (e.g., gastrocnemius muscle, soleus muscle, tibialis posterior muscle)

Exclusion Criteria:

patients whose adverse drug reactions (ADRs)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients aged 2-year or older

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009128	Muscle Spasticity

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009122	Muscle Hypertonia
D020879	Neuromuscular Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided