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Gabapentin and pregabalin are treatments for some types of neuropathic pain, including postherpetic neuralgia (PHN). However, these treatments usually need to be taken 3 times a day for effective pain control. The purpose of this study is to determine whether a new gabapentin tablet, which only needs to be taken once a day, is safe and effective for the treatment of postherpetic neuralgia.
The primary study objective is to assess the relative efficacy of G-ER dosed once daily (1800 mg following the evening meal), versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period (Treatment Week 10) in patients with PHN.
Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores, Short-Form McGill Pain Questionnaire (SF-MPQ), the Neuropathic Pain Scale (NPS), Brief Pain Inventory (BPI), Patient Global Impression of Change (PGIC), and Investigator-Rated Clinical Global Impression of Change (CGIC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-ER | Experimental | Gabapentin - Extended Release |
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| Placebo | Placebo Comparator | Sugar pill |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin Extended Release tablets | Drug | Once-Daily; 300 mg and 600 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score | Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10). | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score | Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10). | 10 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27037091 | Derived | Mehta N, Bucior I, Bujanover S, Shah R, Gulati A. Relationship between pain relief, reduction in pain-associated sleep interference, and overall impression of improvement in patients with postherpetic neuralgia treated with extended-release gabapentin. Health Qual Life Outcomes. 2016 Apr 1;14:54. doi: 10.1186/s12955-016-0456-0. |
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Study included screening visit, wash-out from all PHN medications as necessary, followed by a week of baseline period. Patients who successfully completed the baseline week, if still continues to meet entry criteria, then get randomized to Active or Placebo groups.
Recruitment period was from March 2008 through May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | G-ER | Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing |
| FG001 | Placebo | Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Once daily; 300 mg and 600 mg tablets |
|
| 10 weeks |
| Clinical Global Impression of Change (CGIC) | Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2). | 10 weeks |
| Average Daily Sleep Interference Score | Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10). | 10 weeks |
| Tuscaloosa |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Little Rock | Arkansas | United States |
| Lancaster | California | United States |
| Los Angeles | California | United States |
| Pismo Beach | California | United States |
| Colorado Springs | Colorado | United States |
| Pueblo | Colorado | United States |
| Daytona Beach | Florida | United States |
| Naples | Florida | United States |
| New Port Richey | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Marietta | Georgia | United States |
| Honolulu | Hawaii | United States |
| Elk Grove Village | Illinois | United States |
| Shreveport | Louisiana | United States |
| West Yarmouth | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Florissant | Missouri | United States |
| Jefferson City | Missouri | United States |
| Albuquerque | New Mexico | United States |
| High Point | North Carolina | United States |
| Bismarck | North Dakota | United States |
| Fargo | North Dakota | United States |
| Canton | Ohio | United States |
| Cincinnati | Ohio | United States |
| Kettering | Ohio | United States |
| Warwick | Rhode Island | United States |
| Murrells Inlet | South Carolina | United States |
| Pelzer | South Carolina | United States |
| Tullahoma | Tennessee | United States |
| Austin | Texas | United States |
| Longview | Texas | United States |
| Spokane | Washington | United States |
| Buenos Aires | Argentina |
| All Over Russia | Russia |
| Saint Petersburg | Russia |
| Safety & Efficacy of Gabapentin ER |
|
| 379 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | G-ER | Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing |
| BG001 | Placebo | Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Of the 452 subjects randomized, 2 subjects were excluded from the intent-to-treat (ITT) population: 1 subject had no baseline data recorded, and 1 subject was randomized twice. Baseline demographics were calculated on the ITT population of 450 participants. | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score | Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10). | ITT, BOCF | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | 10 weeks |
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| Secondary | Patient Global Impression of Change (PGIC) | Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2). | ITT, BOCF | Posted | Number | Participants | 10 weeks |
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| Secondary | Clinical Global Impression of Change (CGIC) | Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as "very much improved" (score = 1) or "much improved" (score = 2). | Posted | Number | Participants | 10 weeks |
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| Secondary | Average Daily Sleep Interference Score | Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10). | Posted | Least Squares Mean | Standard Error | Scores on a scale | 10 weeks |
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| Other Pre-specified | Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score | Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10). | Posted | Least Squares Mean | Standard Error | Scores on a scale | 10 weeks |
|
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11 weeks (plus 30 days for SAEs)
AEs and SAEs collected from signing of consent form through completion of Tapering Week Visit (Week 11); SAEs collected for 30 days after completion of Tapering Week (Week 11).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | G-ER | Gabapentin Extended Release 1800 mg once daily (qd); 300 mg and 600 mg tablets, oral dosing | 4 | 221 | 92 | 221 | ||
| EG001 | Placebo | Placebo 1800 mg once daily (qd); 300 mg and 600 mg sugar pills, oral dosing | 6 | 231 | 63 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestion | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
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| Left arm fracture | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Pancoast tumor | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA (9.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Peripheral edema | General disorders | MedDRA (9.0) | Systematic Assessment |
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| Post herpetic neuralgia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (9.0) | Systematic Assessment |
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| Weight increased | Investigations | MedDRA (9.0) | Systematic Assessment |
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The PI agree that the sponsor shall have the right to the first publication of the results of the study which is intended to be joint, multi-center publication. Following the first publication, the PI may publish data or results from the study, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the data of the proposed publication.Sponsor may remove any information that is considered confidential and or proprietary other than study data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of R&D | Depomed | 650-462-5900 | 108 | msweeney@depomed.com |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| 65 to 74 years |
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| >=75 years |
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| Male |
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| Black |
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| Asian |
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| Other |
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