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NCT00567268
Drug Use Investigation Of Gabapen
trial testing Gabapentin in Epilepsies, Partial in 1,273 participants. Completed in 1 May 2014.
1 May 2014
Quick facts
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,273 |
| Start date | 1 August 2007 |
| Primary completion | 1 May 2014 |
| Estimated completion | 1 May 2014 |
Drugs / interventions tested
- Gabapentin (Gabapentin) — full drug profile →
Conditions studied
- Epilepsies, Partial — all drugs for Epilepsies, Partial →
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →
Who can join
Eligibility, any sex, with Epilepsies, Partial. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00567268
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gabapentin
Trials testing the same drug.
- NCT07047040 — Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin · Phase 2, PHASE3 · not yet recruiting
- NCT07131527 — Comparison Between Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia Laparoscopic Cholecystectomy · NA · recruiting
- NCT04613024 — Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty · EARLY_PHASE1 · withdrawn
- NCT07389551 — Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic · NA · completed
- NCT06992427 — High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Che · Phase 3 · recruiting
Other recruiting trials for Epilepsies, Partial
Currently open trials in the same condition.
- NCT06550726 — High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy · NA · recruiting
- NCT06967012 — A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures · Phase 4 · recruiting
- NCT06590896 — Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures · Phase 2 · recruiting
- NCT05248269 — Thermocoagulation in Drug Resistant Focal Epilepsy · NA · active not recruiting
- NCT04309812 — Transcranial Direct Current to Treat Epilepsy at Home · NA · active not recruiting
Other Pfizer's Upjohn has merged with Mylan to form Viatris Inc. trials
Trials by the same sponsor.
- NCT04391868 — A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form · Phase 1 · withdrawn
- NCT04176367 — An Bioequivalence Study Comparing Nicergoline 10 mg Tablet Manufactured in China With Nicergoline 10 mg Tablet Manufactu · Phase 1 · completed
- NCT03768726 — Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents · Phase 3 · terminated
- NCT03711708 — Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets · Phase 4 · completed
- NCT03342690 — Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure) · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00567268 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Last refreshed: 1 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00567268.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing