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1 Trial |  |
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- |||| Clinical: Interestingly, In 2019, FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) When used with CNS depressants or in patients with lung problems https://t.co/e0NvhpBGFm. (Twitter) - Sep 22, 2022
- | Lyrica CR (pregabalin CR) / Pfizer
Enrollment closed: Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - Jan 19, 2022
P=N/A, N=600, Active, not recruiting, Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Recruiting --> Active, not recruiting
- ||| Lyrica CR (pregabalin CR) / Pfizer
Clinical, P3 data, Journal: Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: a Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial. (Pubmed Central) - May 21, 2021
P3
Owing to the once-daily administration, treatment effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907.
- ||| Lyrica CR (pregabalin CR) / Pfizer
Enrollment open: Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - Jan 11, 2021
P=N/A, N=600, Recruiting, Sponsor: Pfizer
ClinicalTrials.gov identifier: NCT03221907. Active, not recruiting --> Recruiting
- || Lyrica CR (pregabalin CR) / Pfizer
PK/PD data, Journal: Development of a Novel Controlled-Release Tablet of Pregabalin: Formulation Variation and Pharmacokinetics in Dogs and Humans. (Pubmed Central) - Jan 6, 2021
The time of the peak plasma concentration at 6 h in the fed state of humans coincided with the results of the study on beagles. The novel TL tablet system of pregabalin may prove to be helpful in developing improved formulations with better continuous drug absorption for OAD administration.
- Lyrica CR (pregabalin CR) / Pfizer
[VIRTUAL] Drug utilization evaluation report for the use of gabapentin and pregabalin at CHI Franciscan () - Dec 26, 2020 - Abstract #ASHP2020ASHP_3171;
Patients will be at high risk of developing respiratory depression or increased risk of opioid overdose death. Best safety practices involve initiating gabapentinoids at the lowest dose and providing education to patients to recognize signs and symptoms of respiratory distress and side effects such as feelings of confusion or disorientation, somnolence, slowed, shallow, or difficulty breathing, and unresponsiveness.
- | Lyrica CR (pregabalin CR) / Pfizer
Journal: Immediate and controlled-release pregabalin for the treatment of epilepsy. (Pubmed Central) - Sep 8, 2020
Considering the disappointing results of the only controlled trial, PGB CR is unlikely to become an established epilepsy treatment anytime soon. Nevertheless, given its peculiar properties and potential advantages, PGB (in either formulation) should be further evaluated in specific populations of patients, especially fragile subjects with several comorbidities and complex polytherapies.
- || Lyrica CR (pregabalin CR) / Pfizer
Enrollment closed: Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - Feb 13, 2020
P=N/A, N=600, Active, not recruiting, Sponsor: Pfizer
Nevertheless, given its peculiar properties and potential advantages, PGB (in either formulation) should be further evaluated in specific populations of patients, especially fragile subjects with several comorbidities and complex polytherapies. Not yet recruiting --> Active, not recruiting
- ||| Clinical: New FDA Drug Safety Communication on gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR): https://t.co/uAGEEeB1yg. (Twitter) - Dec 19, 2019
- |||||| Lyrica CR (pregabalin CR) / Pfizer
New trial: Post-marketing Surveillance (PMS) to Observe the Safety and Effectiveness of Lyrica CR Extended Release Tablets (clinicaltrials.gov) - Nov 20, 2019
P, N=600, Not yet recruiting, Sponsor: Pfizer
- | Lyrica CR (pregabalin CR) / Pfizer
Journal: Customized Novel Design of 3D Printed Pregabalin Tablets for Intra-Gastric Floating and Controlled Release Using Fused Deposition Modeling. (Pubmed Central) - Nov 3, 2019
The optimized formulation (F6) with partially opened top layer showed zero-order drug release. The results show that FDM printing is suitable for the formulation of floating dosage form with the desired drug release profile.
- | Lyrica CR (pregabalin CR) / Pfizer
Clinical, PK/PD data, Journal: Comparative Pharmacokinetics of a Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and an Immediate-release Pregabalin Capsule in Healthy Male Volunteers. (Pubmed Central) - Oct 25, 2019
P1
A high-fat diet significantly increased the bioavailability of the GLA5PR GLARS-NF1 tablet. ClinicalTrials.gov identifiers: NCT01638273 and NCT02326987.
- | Lyrica CR (pregabalin CR) / Pfizer
Journal: Controlled-release pregabalin in the treatment of fibromyalgia. (Pubmed Central) - May 11, 2019
...Together with the antidepressants duloxetine and milnacipran, the anticonvulsant pregabalin (PGB) is one of the three drugs approved by the Food and Drug Administration for the treatment of FM...Expert opinion: Although there are no published studies specifically comparing PGB-CR and PGB-IR formulations in FM patients, the efficacy and safety profiles of PGB-CR seem to be similar to those of the IR formulation, and the convenience of once-daily dosing potentially enhances patient compliance. However, the amount of evidence is not sufficient to draw any definite conclusions, and further studies of larger patient samples are needed.
- | Lyrica CR (pregabalin controlled-release) / Pfizer
Clinical, PK/PD data, Journal: Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study. (Pubmed Central) - Mar 25, 2019
P1
The safety evaluations showed no clinically significant finding after administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state. The dose-proportional properties of GLA5PR GLARS-NF1 150-450 mg tablets were determined.
- | Lyrica CR (pregabalin CR) / Pfizer
Trial completion: Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers (clinicaltrials.gov) - Jul 7, 2016
P1, N=25, Completed, Sponsor: Pfizer
The dose-proportional properties of GLA5PR GLARS-NF1 150-450 mg tablets were determined. Recruiting --> Completed
- | Lyrica CR (pregabalin CR) / Pfizer
New P1 trial: Bioavailability Study of Pregabalin Extended Release Formulation With Various Release Rates in Healthy Volunteers (clinicaltrials.gov) - Mar 31, 2016
P1, N=24, Recruiting, Sponsor: Pfizer
- ||||||| Lyrica CR (pregabalin CR) / Pfizer
Trial completion: Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (clinicaltrials.gov) - Oct 17, 2014
P3, N=800, Completed, Sponsor: Pfizer
Recruiting --> Completed Recruiting --> Completed
- |||||| Lyrica CR (pregabalin CR) / Pfizer
Enrollment open: Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (clinicaltrials.gov) - Oct 15, 2014
P3, N=800, Recruiting, Sponsor: Pfizer
Recruiting --> Completed Suspended --> Recruiting
- || Lyrica CR (pregabalin CR) / Pfizer
Trial completion, Trial suspension: Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (clinicaltrials.gov) - Sep 24, 2014
P3, N=800, Completed, Sponsor: Pfizer Inc.`Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Suspended --> Recruiting Ongoing --> Completed | Ongoing --> Suspended
- || Lyrica CR (pregabalin CR) / Pfizer
Trial suspension: Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (clinicaltrials.gov) - May 8, 2014
P3, N=800, Suspended, Sponsor: Pfizer
Ongoing --> Completed | Ongoing --> Suspended Recruiting --> Suspended
- ||||| Lyrica CR (pregabalin CR) / Pfizer
Enrollment change: Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients (clinicaltrials.gov) - Sep 12, 2012
P3, N=777, Completed, Sponsor: Pfizer
Recruiting --> Suspended N=290 --> 777
- ||||||| Lyrica CR (pregabalin CR) / Pfizer
Trial completion: Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients (clinicaltrials.gov) - Sep 12, 2012
P3, N=777, Completed, Sponsor: Pfizer
N=290 --> 777 Recruiting --> Completed
- ||||| Lyrica CR (pregabalin CR) / Pfizer
Enrollment change: Once-A-Day Pregabalin For Partial Seizures (clinicaltrials.gov) - Aug 19, 2012
P3, N=334, Completed, Sponsor: Pfizer
Recruiting --> Completed N=264 --> 334
- ||||||| Lyrica CR (pregabalin CR) / Pfizer
Trial completion: Once-A-Day Pregabalin For Partial Seizures (clinicaltrials.gov) - Aug 19, 2012
P3, N=334, Completed, Sponsor: Pfizer
N=264 --> 334 Active, not recruiting --> Completed
- | Lyrica CR (pregabalin CR) / Pfizer
Trial completion: A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted (clinicaltrials.gov) - Apr 16, 2012
P1, N=16, Completed, Sponsor: Pfizer
Active, not recruiting --> Completed Recruiting --> Completed
- | Lyrica CR (pregabalin CR) / Pfizer
New P1 trial: A 5-treatment, Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release (CR) Pregabalin Tablet Formulations and the Immediate Release (IR) Formulation Administered Fasted (clinicaltrials.gov) - Sep 26, 2011
P1, N=16, Completed, Sponsor: Pfizer