Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN)
OBJECTIVE:To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg). METHODS:This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titratio...
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| Veröffentlicht in: | The Clinical journal of pain 2013-04, Vol.29 (4), p.281-288 |
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| container_title | The Clinical journal of pain |
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| creator | Sang, Christine N Sathyanarayana, Rekha Sweeney, Michael |
| description | OBJECTIVE:To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg).
METHODS:This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation.
RESULTS:Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (−2.1 vs. −1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported “much” or “very much” improvement (patient global impression of change, 43% vs. 34%; P |
| doi_str_mv | 10.1097/AJP.0b013e318258993e |
| format | Article |
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METHODS:This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation.
RESULTS:Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (−2.1 vs. −1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported “much” or “very much” improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (−2.3 vs. −1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%).
CONCLUSION:Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.</description><identifier>ISSN: 0749-8047</identifier><identifier>EISSN: 1536-5409</identifier><identifier>DOI: 10.1097/AJP.0b013e318258993e</identifier><identifier>PMID: 22801243</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Amines - administration & dosage ; Amines - therapeutic use ; Analgesics - administration & dosage ; Analgesics - therapeutic use ; Cyclohexanecarboxylic Acids - administration & dosage ; Cyclohexanecarboxylic Acids - therapeutic use ; Delayed-Action Preparations ; Double-Blind Method ; Drug Administration Schedule ; Female ; gamma-Aminobutyric Acid - administration & dosage ; gamma-Aminobutyric Acid - therapeutic use ; Humans ; Male ; Middle Aged ; Neuralgia, Postherpetic - drug therapy ; Pain Measurement ; Severity of Illness Index ; Treatment Outcome</subject><ispartof>The Clinical journal of pain, 2013-04, Vol.29 (4), p.281-288</ispartof><rights>2013 Lippincott Williams & Wilkins, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c381e-4a1d16bb9c5eb8695feeb2196eae1c068ac90337cca8768428b3d0d1ebe547af3</citedby><cites>FETCH-LOGICAL-c381e-4a1d16bb9c5eb8695feeb2196eae1c068ac90337cca8768428b3d0d1ebe547af3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22801243$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sang, Christine N</creatorcontrib><creatorcontrib>Sathyanarayana, Rekha</creatorcontrib><creatorcontrib>Sweeney, Michael</creatorcontrib><creatorcontrib>DM-1796 Study Investigators</creatorcontrib><title>Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN)</title><title>The Clinical journal of pain</title><addtitle>Clin J Pain</addtitle><description>OBJECTIVE:To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg).
METHODS:This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation.
RESULTS:Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (−2.1 vs. −1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported “much” or “very much” improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (−2.3 vs. −1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%).
CONCLUSION:Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amines - administration & dosage</subject><subject>Amines - therapeutic use</subject><subject>Analgesics - administration & dosage</subject><subject>Analgesics - therapeutic use</subject><subject>Cyclohexanecarboxylic Acids - administration & dosage</subject><subject>Cyclohexanecarboxylic Acids - therapeutic use</subject><subject>Delayed-Action Preparations</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>gamma-Aminobutyric Acid - administration & dosage</subject><subject>gamma-Aminobutyric Acid - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neuralgia, Postherpetic - drug therapy</subject><subject>Pain Measurement</subject><subject>Severity of Illness Index</subject><subject>Treatment Outcome</subject><issn>0749-8047</issn><issn>1536-5409</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMFO3DAURa2Kqkxp_6BCXs4sQv1sJ7GXIwSBCtERatVlZDsvjNtMPNgOiL9v0NAuuujqvsW590mHkE_AzoDp-vP6y-aMWQYCBSheKq0FviELKEVVlJLpI7JgtdSFYrI-Ju9T-skYlFyxd-SYzwFcigXJjUk5hogZx-wfkTbGmv3LPdJlUzR3K3oZ4m4aTPZhpHfYTQ4TvR5nPvn8TENPN2aG1ykF503Gjv7weUs3IeUtxj1m7-gtTtEM997Q5ebqdvWBvO3NkPDja56Q75cX386vipuvzfX5-qZwQgEW0kAHlbXalWhVpcse0XLQFRoExyplnGZC1M4ZVVdKcmVFxzpAi6WsTS9OyPKwu4_hYcKU251PDofBjBim1IIAWYPgnM-oPKAuhpQi9u0--p2Jzy2w9sV3O_tu__U9105fP0x2h93f0h_BM6AOwFMYMsb0a5ieMLZbNEPe_n_7N0i5jww</recordid><startdate>201304</startdate><enddate>201304</enddate><creator>Sang, Christine N</creator><creator>Sathyanarayana, Rekha</creator><creator>Sweeney, Michael</creator><general>Lippincott Williams & Wilkins, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201304</creationdate><title>Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN)</title><author>Sang, Christine N ; Sathyanarayana, Rekha ; Sweeney, Michael</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c381e-4a1d16bb9c5eb8695feeb2196eae1c068ac90337cca8768428b3d0d1ebe547af3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Amines - administration & dosage</topic><topic>Amines - therapeutic use</topic><topic>Analgesics - administration & dosage</topic><topic>Analgesics - therapeutic use</topic><topic>Cyclohexanecarboxylic Acids - administration & dosage</topic><topic>Cyclohexanecarboxylic Acids - therapeutic use</topic><topic>Delayed-Action Preparations</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>gamma-Aminobutyric Acid - administration & dosage</topic><topic>gamma-Aminobutyric Acid - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neuralgia, Postherpetic - drug therapy</topic><topic>Pain Measurement</topic><topic>Severity of Illness Index</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sang, Christine N</creatorcontrib><creatorcontrib>Sathyanarayana, Rekha</creatorcontrib><creatorcontrib>Sweeney, Michael</creatorcontrib><creatorcontrib>DM-1796 Study Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Clinical journal of pain</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sang, Christine N</au><au>Sathyanarayana, Rekha</au><au>Sweeney, Michael</au><aucorp>DM-1796 Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN)</atitle><jtitle>The Clinical journal of pain</jtitle><addtitle>Clin J Pain</addtitle><date>2013-04</date><risdate>2013</risdate><volume>29</volume><issue>4</issue><spage>281</spage><epage>288</epage><pages>281-288</pages><issn>0749-8047</issn><eissn>1536-5409</eissn><abstract>OBJECTIVE:To evaluate the safety and efficacy of a once-daily gastroretentive formulation of gabapentin (G-GR; 1800 mg).
METHODS:This was an 11-week, double-blind, randomized, placebo-controlled Phase 3 clinical trial in patients with postherpetic neuralgia. Patients underwent a 2-week dose titration, 8 weeks of stable dosing, and 1 week of dose tapering. The primary endpoint was the change in average daily pain intensity score from Baseline to Week 10 using Baseline Observation Carried Forward (BOCF) imputation.
RESULTS:Four-hundred and fifty-two patients (mean age 65.6 y, BMI 29 Kg/m) were randomized. Baseline average daily pain intensity score during the week prior to randomization was 6.6 and 6.5 for the G-GR and placebo treatment groups, respectively. Three hundred and seventy-seven patients completed the study (84% G-GR, 83% placebo). G-GR significantly reduced BOCF change in average daily pain intensity compared with placebo (−2.1 vs. −1.6; G-GR vs. placebo, P=0.013). Compared with placebo, more G-GR-treated patients reported “much” or “very much” improvement (patient global impression of change, 43% vs. 34%; P<0.0434), and G-GR reduced sleep interference (−2.3 vs. −1.59; P<0.0001), although neither endpoint was considered statistically significant based on a stringent hierarchical statistical paradigm. Other secondary endpoints showed similar trends. The most common adverse events were dizziness (G-GR, 11.3% vs. placebo, 1.7 %) and somnolence (G-GR, 5.4% vs. placebo, 3.0%).
CONCLUSION:Once-daily G-GR 1800 mg was effective and well tolerated for the relief of pain in patients with postherpetic neuralgia.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins, Inc</pub><pmid>22801243</pmid><doi>10.1097/AJP.0b013e318258993e</doi><tpages>8</tpages></addata></record> |
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| subjects | Adult Aged Aged, 80 and over Amines - administration & dosage Amines - therapeutic use Analgesics - administration & dosage Analgesics - therapeutic use Cyclohexanecarboxylic Acids - administration & dosage Cyclohexanecarboxylic Acids - therapeutic use Delayed-Action Preparations Double-Blind Method Drug Administration Schedule Female gamma-Aminobutyric Acid - administration & dosage gamma-Aminobutyric Acid - therapeutic use Humans Male Middle Aged Neuralgia, Postherpetic - drug therapy Pain Measurement Severity of Illness Index Treatment Outcome |
| title | Gastroretentive Gabapentin (G-GR) Formulation Reduces Intensity of Pain Associated With Postherpetic Neuralgia (PHN) |
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