Renal ImpairmentPhase 4NCT00785772

A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment

A Phase 4 study testing Gabapentin in people with Renal Impairment, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant differences between the plasma gabapentin concentration simulated by population PK model, which was… Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Renal Impairment
What is being tested?: Gabapentin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteJapan
Study dates: Mar 2010to Apr 2010
Phase: Phase 4
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 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Japanese epilepsy patients with renal impairment

Who cannot join

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Investigational Site
Saijyo-shi, Ehime

Other trials in Japan

About this study

Read the detailed description

Only one subject was able to be enrolled. Given enrollment challenges to identify additional appropriate subjects, discussion was held with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and it was agreed with the PMDA to terminate this study. The study was terminated on December 14, 2010. The study was not terminated due to any safety findings.

Conditions: Renal Impairment
Being tested: Gabapentin
Keywords: Gabapentin Pharmacokinetics
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GabapentinDrug
100-200mg once a day
GabapentinDrug
200-500mg once a day
GabapentinDrug
400-1000mg (200-500 mg twice a day)

Study groups in NCT00785772
Study group	Role	What they receive
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min	Experimental	Not described Receives: Drug: Gabapentin
2: Patients with CLcr 15-29 mL/min	Experimental	Not described Receives: Drug: Gabapentin
3: Patients with CLcr 30-59 mL/min	Experimental	Not described Receives: Drug: Gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

Observed Plasma Gabapentin Concentration
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Measured: Days 8 and 15
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
Measured: Days 8 and 15
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.
Measured: Days 8 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Apr 2010

First posted5 Nov 2008 (estimated)
Study startMar 2010
Primary completionApr 2010
Study completionApr 2010

Why it stopped: See termination reason in detailed description.

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 Renal ImpairmentStudies 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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00785772
Sponsor's protocol ID: A9451169
Status last verified: Oct 2011
First submitted: 3 Nov 2008
Last updated: 3 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

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: A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
ClinicalTrials.gov ID: NCT00785772
Acronym / sponsor ID: A9451169
Conditions: Renal Impairment
Keywords: Gabapentin Pharmacokinetics
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 1 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 5 Nov 2008 (estimated)
Results: Posted 27 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min	Experimental	Drug: Gabapentin
2: Patients with CLcr 15-29 mL/min	Experimental	Drug: Gabapentin
3: Patients with CLcr 30-59 mL/min	Experimental	Drug: Gabapentin

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Japanese epilepsy patients with renal impairment

Key exclusion criteria (1 listed)

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
Gabapentin100-200mg once a day	Drug	1: Patients with Cleatinine Clearance (CLcr) 5-14 mL/min
Gabapentin200-500mg once a day	Drug	2: Patients with CLcr 15-29 mL/min
Gabapentin400-1000mg (200-500 mg twice a day)	Drug	3: Patients with CLcr 30-59 mL/min

Primary outcome

Observed Plasma Gabapentin Concentration
Time frame: Days 8 and 15
Plasma gabapentin concentrations were measured on Day 8 and Day 15
Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
Time frame: Days 8 and 15
Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively.
Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
Time frame: Days 8 and 15
Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively.

Results and safety

Results posted to the registry on 27 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gabapentin	1	1

Primary outcome: Observed Plasma Gabapentin Concentration

Time frame: Days 8 and 15. Mean (Full Range). Unit: µg/mL

Measure	Gabapentin n = 1
Day 8	38.40 (38.40 to 38.40)
Day 15	44.64 (44.64 to 44.64)

Population analysed: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.

Primary outcome: Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model

Time frame: Days 8 and 15. Number. Unit: Ratio

Measure	Gabapentin n = 1
Day 8	2.16
Day 15	2.59

Population analysed: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.

Primary outcome: Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration

Time frame: Days 8 and 15. Number. Unit: Ratio

Measure	Gabapentin n = 1
Day 8	1.15
Day 15	1.37

Population analysed: The Pharmacokinetics (PK) concentration analysis population is defined as all subjects treated who have at least 1 of the PK parameters of interest.

Adverse events

Time frame: From Day -7 (informed consent) until 28 days after the end of study treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gabapentin	0 of 1 (0%)	0 of 1 (0%)	Not reported

Limitations and caveats (from the sponsor): The study was completed with an enrollment of 1 subject because prolongation of the study period or a change in the inclusion criteria (the upper limit of age was deleted) did not lead to further enrollment of subjects.

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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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gabapentin in people with Renal Impairment, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.

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: stopped early, 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.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2011). 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?

Observed Plasma Gabapentin Concentration (time frame: Days 8 and 15). 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?

On the ClinicalTrials.gov record for NCT00785772.

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.