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Pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. This study will compare the efficacy of pregabalin when administered with an experimental drug PF-00489791, in patients with post-herpetic neuralgia. The efficacy of this combination will be compared to pregabalin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pregabalin | Drug | 75mg bid titrating to 150mg bid on day 4 |
| |
| pregabalin/PF-00489791 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Score on Daily Pain Rating Scale (DPRS) | Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error. | End of treatment period (included both Week 2 and Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Patient Global Impression of Change (PGIC) Score | The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week6]) was calculated and reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama RadioPharmacy | Huntsville | Alabama | 35801 | United States | ||
| Tennessee Valley Pain Consultants |
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin Then Placebo | Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention Period (2 Weeks) |
|
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| Drug |
Pregabalin 75mg bid titrating to 150mg bid on day 4; PF-00489791: 4mg od titrating to 10mg od on day 4 |
|
| Placebo | Drug | Placebo |
|
| End of treatment period (included both Week 2 and Week 6) |
| Pain Visual Analogue Scale (VAS) at Baseline and Week 4 | Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain. | Baseline, Week 4 |
| Neuropathic Pain Symptom Inventory (NPSI) | Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like [item 1 to 3]: burning, squeezing, pressure; painful attack like [item 4 to 5]: electric shock, stabbing; pain provoked on [item 6 to 8]: light touching, pressure, contact with something cold; abnormal sensations like [item 9 to 10]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week 6]) was calculated and reported in terms of adjusted mean and standard error. | End of treatment period (included both Week 2 and Week 6) |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator. | Baseline up to Week 7 |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (<) 480 milliseconds (msec), 480 to <500 msec and greater than equal to (>=) 500 msec; Maximum QTc interval increase from baseline: >=30 to <60 and >=60 (msec); PR interval: >=300 msec and percent change >=25 or 50 percent; QRS complex: percent change >=25 or 50 percent. Clinical significance was judged by investigator. | Baseline up to Week 7 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology | Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator. | Baseline up to Week 7 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry | Criteria for clinical chemistry abnormalities included total bilirubin: greater than (>) 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: >3.0*ULN; total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN; potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN. Clinical significance was judged by investigator. | Baseline up to Week 7 |
| Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis | Urinalysis abnormalities criteria included: urine specific gravity: <1.003 to >1.030; urine pH: <4.5 to >8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: >=1. Clinical significance was judged by investigator. | Baseline up to Week 7 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| River Region Research, LLC | Tallassee | Alabama | 36078 | United States |
| Radiant Research | Chandler | Arizona | 85225 | United States |
| Novara Clinical Research | Mesa | Arizona | 85206 | United States |
| Community Medical Providers | Clovis | California | 93611 | United States |
| Sierra Medical Research (Administrative only site) | Fresno | California | 93710 | United States |
| Prime-Care Clinical Research | Mission Viejo | California | 92691 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Bradenton Research Center | Bradenton | Florida | 34205 | United States |
| Arthritis Associates of South Florida | Delray Beach | Florida | 33484 | United States |
| Delray Research Associates | Delray Beach | Florida | 33484 | United States |
| Office of Laszlo J Mate, M.D. | West Palm Beach | Florida | 33407 | United States |
| American Medical Research, Inc. | Oak Brook | Illinois | 60523 | United States |
| Beacon Clinical Research | Brockton | Massachusetts | 02301 | United States |
| ICPS Group | Norwood | Massachusetts | 02062 | United States |
| Neurological Research Center at Hattiesburg Clinic | Hattiesburg | Mississippi | 39401-7246 | United States |
| CRC of Jackson | Jackson | Mississippi | 39202 | United States |
| Physician's Surgery Center | Jackson | Mississippi | 39202 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| Centennial Park Medical Building | North Platte | Nebraska | 69101 | United States |
| Neurology Associates of Great Plains | North Platte | Nebraska | 69101 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| North State Clinical Research, PLLC | Lenoir | North Carolina | 28645 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Legacy Pharma Research | Bismarck | North Dakota | 58501 | United States |
| Patient Priority Clinical Sites, LLC | Cincinnati | Ohio | 45242 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Mark A. Fisher, MD-Private Practice | Oklahoma City | Oklahoma | 73112 | United States |
| Absolute Primary Care, P.C. | Cranberry Twp. | Pennsylvania | 16066 | United States |
| John P. Murtha Neuroscience and Pain Institute | Johnstown | Pennsylvania | 15904 | United States |
| Memorial Medical Center | Johnstown | Pennsylvania | 15905 | United States |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | United States |
| Medical Clinic of North Texas | Arlington | Texas | 76012 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78756 | United States |
| Futuresearch Trials | Austin | Texas | 78756 | United States |
| Pinnacle Pain Medicine | Dallas | Texas | 75231 | United States |
| The Medical Group Of Texas | Fort Worth | Texas | 76104 | United States |
| Medical and Surgical Clinic of Irving | Irving | Texas | 75061 | United States |
| FG001 | Placebo Then Pregabalin | Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| FG002 | Pregabalin + Placebo Then Pregabalin + PF-00489791 | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| FG003 | Pregabalin + PF-00489791 Then Pregabalin + Placebo | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout Period (2 Weeks) |
|
|
| Second Intervention Period (2 Weeks) |
|
|
Safety analysis set included all participants who were randomized and had received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin Then Placebo | Participants received 75 milligram (mg) capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first intervention period followed by placebo matched to Pregabalin twice daily from Day 1 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| BG001 | Placebo Then Pregabalin | Participants received placebo matched to Pregabalin twice daily from Day 1 to Day 14 in first intervention period followed by Pregabalin 75 mg capsule orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in second intervention period. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| BG002 | Pregabalin + Placebo Then Pregabalin + PF-00489791 | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with placebo matched to PF-00489791 orally once daily from Day 1 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| BG003 | Pregabalin + PF-00489791 Then Pregabalin + Placebo | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 orally once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 orally once daily from Day 4 to Day 14 in first intervention period. In second intervention period participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with a placebo matched to PF-00489791 orally once daily from Day 1 to Day 14. A washout period of at least 14 days was maintained between each intervention period. Participants had follow up of 1 week. |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Pain Score on Daily Pain Rating Scale (DPRS) | Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error. | Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Error | units on a scale | End of treatment period (included both Week 2 and Week 6) |
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| Secondary | Percentage of Participants With Patient Global Impression of Change (PGIC) Score | The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week6]) was calculated and reported. | Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | End of treatment period (included both Week 2 and Week 6) |
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| Secondary | Pain Visual Analogue Scale (VAS) at Baseline and Week 4 | Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain. | Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Number Analyzed" signifies the number of participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mm | Baseline, Week 4 |
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| Secondary | Neuropathic Pain Symptom Inventory (NPSI) | Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like [item 1 to 3]: burning, squeezing, pressure; painful attack like [item 4 to 5]: electric shock, stabbing; pain provoked on [item 6 to 8]: light touching, pressure, contact with something cold; abnormal sensations like [item 9 to 10]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week 6]) was calculated and reported in terms of adjusted mean and standard error. | Full analysis set included all participants who were randomized and had received at least 1 dose of study drug, regardless of whether they had efficacy data and did not have any significant protocol violation. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Error | units on a scale | End of treatment period (included both Week 2 and Week 6) |
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| Secondary | Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator. | Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Week 7 |
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| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (<) 480 milliseconds (msec), 480 to <500 msec and greater than equal to (>=) 500 msec; Maximum QTc interval increase from baseline: >=30 to <60 and >=60 (msec); PR interval: >=300 msec and percent change >=25 or 50 percent; QRS complex: percent change >=25 or 50 percent. Clinical significance was judged by investigator. | Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Baseline up to Week 7 |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Hematology | Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator. | Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to Week 7 |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Clinical Chemistry | Criteria for clinical chemistry abnormalities included total bilirubin: greater than (>) 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: >3.0*ULN; total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN; potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN. Clinical significance was judged by investigator. | Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. Here "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to Week 7 |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities: Urinalysis | Urinalysis abnormalities criteria included: urine specific gravity: <1.003 to >1.030; urine pH: <4.5 to >8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: >=1. Clinical significance was judged by investigator. | Safety analysis set included all participants who were randomized and had received at least 1 dose of study medication. Here "Overall Number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to Week 7 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study. Safety data was summarized using randomized patients that took at least 1 dose of study medication.
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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 | Pregabalin + PF-00489791 | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 along with two tablets of 2 mg PF-00489791 once daily from Day 1 to Day 3 and 10 mg tablet of PF-00489791 once daily from Day 4 to Day 14 in first or second intervention period. | 1 | 38 | 22 | 38 | ||
| EG001 | Pregabalin | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period. | 0 | 61 | 35 | 61 | ||
| EG002 | Placebo | Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. | 0 | 26 | 7 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | General disorders | MedDRA v11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Faecal incontinence | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Anorectal infection | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v11.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v11.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Withdrawal syndrome | Psychiatric disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Penis disorder | Reproductive system and breast disorders | MedDRA v11.1 | Non-systematic Assessment | This event was gender specific. |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA v11.1 | Non-systematic Assessment | This event was gender specific. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Sinus operation | Surgical and medical procedures | MedDRA v11.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v11.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v11.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Adverse Event |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 0.0002 |
| Adjusted Mean Difference |
| -1.32 |
| Standard Error of the Mean |
| 0.357 |
| 2-Sided |
| 80 |
| -1.78 |
| -0.86 |
| Superiority or Other (legacy) |
Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period. |
| OG002 | Placebo | Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. |
|
|
|
Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. |
|
|
| OG001 | Pregabalin | Participants received 75 mg capsule of Pregabalin orally twice daily from Day 1 to Day 3 and 150 mg capsule of Pregabalin orally twice daily from Day 4 to Day 14 in first or second intervention period. |
| OG002 | Placebo | Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. |
|
|
|
|
|
| OG002 |
| Placebo |
Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. |
|
|
Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period.
|
|
| OG002 | Placebo | Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. |
|
|
Participants received placebo matched to Pregabalin capsule from Day 1 to Day 14 in first or second intervention period. |
|
|