Epilepsies, PartialNCT00567268
Drug Use Investigation Of Gabapentin
An observational study of Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,273 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to May 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A9451163 prescribes the Gabapentin
Who may be able to join
- Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Who cannot join
- Patients not taking Gabapentin
About this study
Official title: Drug Use Investigation Of Gabapen
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Read the detailed description
All the patients whom an investigator prescribes the first Gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
- Conditions
- Epilepsies, Partial
- Being tested
- Gabapentin
- Keywords
- Post-Marketing surveillance
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
GABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan.
Dosage, frequency: According to Japanese LPD, "Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg)".
Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Patients taking Gabapentin Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
Measured: 12 weeks
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 sponsor (Pfizer Japan Inc.).
Measured: 12 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 for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
Measured: 12 weeks
Secondary outcomes (3)
Response Ratio (R Ratio)
Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure.
Measured: 12 weeks
Responder Rate
Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.
Measured: 12 weeks
Percent Reduction From Baseline in Epileptic Seizure Frequency
Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567268
- Sponsor's protocol ID
- A9451163
- Status last verified
- Sep 2015
- First submitted
- 16 Nov 2007
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation Of Gabapen
- ClinicalTrials.gov ID
- NCT00567268
- Acronym / sponsor ID
- A9451163
- Conditions
- Epilepsies, Partial
- Keywords
- Post-Marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,273 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes the first Gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | – | Drug: GabapentinPatients taking Gabapentin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A9451163 prescribes the Gabapentin
Key inclusion criteria (1 listed)
- Patients need to be taking Gabapentin in order to be enrolled in the surveillance
Key exclusion criteria (1 listed)
- Patients not taking Gabapentin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinGABAPEN Tablets 200mg, GABAPEN Tablets 300mg, GABAPEN Tablets 400mg. GABAPEN is Brand name in Japan. Dosage, frequency: According to Japanese LPD, "Normally, oral gabapentin 600 mg, 3 div., should be given on the first day of administration and an effective dose of 1200mg, 3 div, should be given on day 2. From day 3 on, adults should be maintained on oral gabapentin 1200 mg to 1800 mg, 3 div. Subsequently, the maintenance dose should be suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg)". Duration: According to the protocol of A9451163, the duration of the investigation for findings regarding safety and efficacy of a patient is from the first drug administration to the 12 weeks after the first administration. | Drug | Gabapentin |
Primary outcome
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
Time frame: 12 weeks
A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the sponsor (Pfizer Japan Inc.).
Number of Participants With Treatment-Related Adverse Events
Time frame: 12 weeks
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 sponsor (Pfizer Japan Inc.).
Clinical Efficacy Rate
Time frame: 12 weeks
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 for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.
3 secondary outcomes
Response Ratio (R Ratio)
Time frame: 12 weeks
Responder Rate
Time frame: 12 weeks
Percent Reduction From Baseline in Epileptic Seizure Frequency
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, Partial, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.