Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)

NCT01441401 | Completed Results

• 1 other identifier: A9451175
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study:

• The frequency of treatment related adverse events.
• The frequency of efficacy assessment.
• Treatment related unlisted adverse events in Japanese Package Insert.
• Risk factors likely to affect the frequency of treatment related adverse event.

Conditions

Epilepsies, Partial

Keywords

Gabapentin; Epilepsies; safety

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).

  MAX 104 weeks

• Clinical Efficacy Rate

  Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.

  MAX 104 weeks

Secondary Outcomes (6)

• Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert

  MAX 104 weeks

• Number of Participants With Risk Factors for Treatment-Related Adverse Events

  MAX 104 weeks

• Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure

  MAX 104 weeks

• Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure

  MAX 104 weeks

• Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline

  MAX 104 weeks

Other Outcomes (5)

• Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)

  MAX 104 weeks

• Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)

  MAX 104 weeks

• Response Ratio (R Ratio)

  MAX 104 weeks

Study Arms (1)

Gabapentin

Peadiatric subjects taking Gabapen Tablets and syrup.

Drug: gabapentin

Interventions

gabapentin DRUG

According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult.

Gabapentin

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study whom an investigator involving A9451175 prescribes the Gabapentin

You may qualify if:

• All the pediatric subjects (aged 3-15 years) whom an investigator prescribes the first gabapentin (tablets, syrup, and switch to syrup from tablet) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

You may not qualify if:

• Patients who have been enrolled in the drug use investigation of Gabapen tablets in adults (protocol No. A9451163).
• Patients who receive Gabapen tablets or syrup before, except for switched from tablets to syrup.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 27, 2011
• Study Start: December 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 3, 2021
• Results First Posted: October 6, 2016

Record last verified: 2016-08