Research and Clinical Trials on Gabapentin (Neurontin, Gabarone)

Gabapentin (Neurontin, Gabarone) Clinical Research Trials

From our searchable database at ClinicalTrialsFeeds.org, this list includes all the latest information about clinical trials involving Gabapentin (Neurontin, Gabarone).

• A Post-Marketing Clinical Pharmakokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
  Status: Not yet recruiting, Condition Summary: Renal Impairment
• Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?
  Status: Recruiting, Condition Summary: Prostate Cancer
• Population Pharmacokinetic-pharmacodynamic (PK-PD) Modeling of Co-administered Gabapentin in Neuropathic Pain
  Status: Recruiting, Condition Summary: Post-traumatic Neuropathic Pain
• Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
  Status: Recruiting, Condition Summary: Benzodiazepine Dependence; Opioid Dependency
• The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section
  Status: Terminated, Condition Summary: Pain
• A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
  Status: Completed, Condition Summary: Postherpetic Neuralgia; Diabetic Neuropathy; Complex Regional Pain Syndrome; Carpal Tunnel Syndrome; HIV Neuropathy; Idiopathic Sensory Neuropathy; Peripheral Neuropathy
• Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study
  Status: Recruiting, Condition Summary: Postoperative Pain; Joint Replacement
• Pilot Study Comparing Hypnotherapy and Gabapentin for Hot Flashes in Breast Cancer Survivors
  Status: Recruiting, Condition Summary: Breast Cancer; Hot Flashes
• Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting
  Status: Enrolling by invitation, Condition Summary: Obesity, Morbid; Postoperative Pain; Postoperative Nausea and Vomiting
• Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
  Status: Active, not recruiting, Condition Summary: Postoperative Pain
• A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Fasting Conditions
  Status: Completed, Condition Summary: Healthy
• A Relative Bioavailability Study of Gabapentin 800 mg Tablets Under Fasting Conditions
  Status: Completed, Condition Summary: Healthy
• A Limited Food Effect Study of Gabapentin 800 mg Tablets
  Status: Completed, Condition Summary: Healthy
• A Relative Bioavailability Study of Gabapentin Tablets 800 mg Under Non-Fasting Conditions
  Status: Completed, Condition Summary: Healthy
• A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting Conditions
  Status: Completed, Condition Summary: Healthy

 

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Current Research Literature on Gabapentin (Neurontin, Gabarone)

Here are abstracts for some of the latest research articles to have appeared on Gabapentin (Neurontin, Gabarone):

Gateways to clinical trials.

Methods Find Exp Clin Pharmacol. 2009 Sep; 31(7): 463-93
Tomillero A, Moral MA
AAV1/SERCA2a, Abacavir sulfate/lamivudine, Adalimumab, Aliskiren fumarate, Ambrisentan, Aripiprazole, AT-7519, Atazanavir sulfate, Atomoxetine hydrochloride, Azacitidine, Azelnidipine; Besifloxacin hydrochloride, Bevacizumab, Bioabsorbable everolimus-eluting coronary stent, Bortezomib, Bosentan, Budesonide/formoterol fumarate; CAIV-T, Carisbamate, Casopitant mesylate, Certolizumab pegol, Cetuximab, Ciclesonide, Ciprofloxacin/dexamethasone, CTCE-9908; Dalcetrapib, Darunavir, Deferasirox, Desloratadine, Disitertide, Drotrecogin alfa (activated), DTA-H19, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Efalizumab, Emtricitabine, Eribulin mesilate, Escitalopram oxalate, Eszopiclone, EUR-1008, Everolimus-eluting coronary stent, Exenatide; Fampridine, Fluticasone furoate, Formoterol fumarate/fluticasone propionate, Fosamprenavir calcium, Fulvestrant; Gabapentin enacarbil, GS-7904L; HPV-6/11/16/18, Human Secretin, Hydralazine hydrochloride/isosorbide dinitrate; Imatinib mesylate, Imexon, Inalimarev/Falimarev, Indacaterol, Indacaterol maleate, Inhalable human insulin, Insulin detemir, Insulin glargine, Ixabepilone; L-Alanosine, Lapatinib ditosylate, Lenalidomide, Levocetirizine dihydrochloride, Liraglutide, Lisdexamfetamine mesilate, Lopinavir, Loratadine/montelukast sodium, Lutropin alfa; MeNZB, Mepolizumab, Micafungin sodium, Morphine hydrochloride; Nabiximols, Nikkomycin Z; Olmesartan medoxomil, Omalizumab; Paclitaxel-eluting stent, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Perifosine, PF-489791, Plitidepsin, Posaconazole, Pregabalin; QAX-576; Raltegravir potassium, Ramelteon, Rasagiline mesilate, Recombinant human relaxin H2, rhGAD65, Rivaroxaban, Rosuvastatin calcium, Rotigotine; Saxagliptin, SCH-530348, Sirolimus-eluting stent, SLIT-amikacin, Sorafenib, Sotrastaurin, SR-16234, Sulforaphane; Tadalafil, Tanespimycin, Tapentadol hydrochloride, Teriparatide, Tesofensine, Tiotropium bromide, Tipifarnib, Tirapazamine, TMC-207, Tocilizumab, Tolvaptan, Tosedostat, Treprostinil sodium; Ustekinumab; Varespladib methyl, Vicriviroc, Vildagliptin, Vildagliptin/metformin hydrochloride, Volociximab, Voriconazole; Ziconotide, Ziprasidone hydrochloride.

Effect of various antiepileptic drugs in a pentylenetetrazol-induced seizure model in mice.

Methods Find Exp Clin Pharmacol. 2009 Sep; 31(7): 423-32
Akula KK, Dhir A, Kulkarni SK
The present study was undertaken to compare the anticonvulsant effect of various antiepileptic drugs on the intravenous pentylenetetrazol (PTZ)-induced seizure threshold in mice. Minimal doses of PTZ needed to induce different phases (myoclonic jerks, generalized clonus and tonic extensor) of convulsions were recorded as an index of seizure threshold. Furthermore, TID(50) (the dose of an anticonvulsant drug required to increase the PTZ seizure threshold for tonic extensor by 50%) was calculated for all drugs, and from these values the potency ratio was determined. Pentobarbital (10-40 mg/kg i.p.), phenobarbital (5-20 mg/kg i.p.), phenytoin (20-40 mg/kg i.p.), carbamazepine (5-20 mg/kg i.p.), diazepam (0.5-2 mg/kg i.p.), chlordiazepoxide (1-4 mg/kg i.p.), triazolam (0.02-0.08 mg/kg i.p.), clonazepam (0.03125-0.25 mg/kg i.p.), GABA (25-100 mg/kg i.p.), ethanol (1000-4000 mg/kg of 10% v/v p.o.), ashwagandha (50-200 mg/kg p.o.), tiagabine (20 and 40 mg/kg i.p.), gabapentin (50-200 mg/kg i.p.), pregabalin (10-40 mg/kg i.p.), progesterone (20-80 mg/kg s.c.), adenosine (25-200 mg/kg i.p.) and rofecoxib (1-4 mg/kg i.p.) exhibited dose-dependent anticonvulsant effects. The TID(50) of triazolam was found to be the lowest among all the drugs tested, indicating higher potency. The relative potency of standard drugs to increase the PTZ seizure threshold for tonic extensor was found to be: triazolam > clonazepam > diazepam > rofecoxib > chlordiazepoxide > phenobarbital > carbamazepine > pentobarbital > pregabalin > phenytoin > progesterone > tiagabine > GABA > adenosine > gabapentin > ashwagandha > ethanol. The results of the present study indicate that the intravenous PTZ seizure threshold may be useful for assessing the anticonvulsant effect of drugs effective against different stages of convulsions.

Outcome reporting in industry-sponsored trials of gabapentin for off-label use.

N Engl J Med. 2009 Nov 12; 361(20): 1963-71
Vedula SS, Bero L, Scherer RW, Dickersin K
BACKGROUND: There is good evidence of selective outcome reporting in published reports of randomized trials. METHODS: We examined reporting practices for trials of gabapentin funded by Pfizer and Warner-Lambert's subsidiary, Parke-Davis (hereafter referred to as Pfizer and Parke-Davis) for off-label indications (prophylaxis against migraine and treatment of bipolar disorders, neuropathic pain, and nociceptive pain), comparing internal company documents with published reports. RESULTS: We identified 20 clinical trials for which internal documents were available from Pfizer and Parke-Davis; of these trials, 12 were reported in publications. For 8 of the 12 reported trials, the primary outcome defined in the published report differed from that described in the protocol. Sources of disagreement included the introduction of a new primary outcome (in the case of 6 trials), failure to distinguish between primary and secondary outcomes (2 trials), relegation of primary outcomes to secondary outcomes (2 trials), and failure to report one or more protocol-defined primary outcomes (5 trials). Trials that presented findings that were not significant (P > or = 0.05) for the protocol-defined primary outcome in the internal documents either were not reported in full or were reported with a changed primary outcome. The primary outcome was changed in the case of 5 of 8 published trials for which statistically significant differences favoring gabapentin were reported. Of the 21 primary outcomes described in the protocols of the published trials, 6 were not reported at all and 4 were reported as secondary outcomes. Of 28 primary outcomes described in the published reports, 12 were newly introduced. CONCLUSIONS: We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.

Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes, N07C1.

J Clin Oncol. 2009 Nov 9;
Loprinzi CL, Qin R, Baclueva EP, Flynn KA, Rowland KM, Graham DL, Erwin NK, Dakhil SR, Jurgens DJ, Burger KN
PURPOSE: Hot flashes are a common problem for which effective and safe treatments are needed. The current trial was conducted on the basis of preliminary promising data that pregabalin decreased hot flashes. PATIENTS AND METHODS: A double-blind, placebo-controlled, randomized trial design was used to compare pregabalin at target doses of 75 mg twice daily and 150 mg twice daily with a placebo. Hot flash frequencies and scores (frequency times mean severity) were recorded daily during a baseline week and for six treatment weeks. The primary end point for this study was the change-from-baseline hot flash score during treatment week 6 between the 150 mg twice daily target pregabalin treatment and placebo. Nonparametric Wilcoxon rank sum tests, two-sample t tests, and chi(2) tests were used to compare the primary and secondary hot flash efficacy end points between pregabalin treatments and placebo. RESULTS: Hot flash score changes available for 163 patients during the sixth treatment week compared with a baseline week decreased by 50%, 65%, and 71% in the placebo, and target 75 mg twice daily and 150 mg twice daily pregabalin arms, respectively (P = .009 and P = .007, comparing respective pregabalin arms to the placebo arm). While some toxicities were significantly more common in the pregabalin arms, being more evident with the higher dose, pregabalin was generally well tolerated by most patients. CONCLUSION: Pregabalin decreases hot flashes and is reasonably well tolerated. A target dose of 75 mg twice daily is recommended. Its effects appear to be roughly comparable to what has been reported with gabapentin and with some newer antidepressants.

Synthesis and in vivo evaluation of 3-substituted gababutins.

Bioorg Med Chem Lett. 2009 Oct 25;
Blakemore DC, Bryans JS, Carnell P, Chessum NE, Field MJ, Kinsella N, Kinsora JK, Osborne SA, Williams SC
A range of 3-alkylated five-membered ring derivatives of Gabapentin were synthesized and several were found to have good levels of potency against the alpha2delta calcium subunit of a voltage-gated calcium channel. Two compounds were profiled in in vivo models of pain and anxiety.