Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to evaluate the analgesic efficacy of ADL5747 in participants with postherpetic neuralgia (PHN). The secondary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of ADL5747.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADL5747 | Experimental | ADL5747 150 milligrams (mg) administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. |
|
| Placebo | Placebo Comparator | Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. |
|
| Pregabalin | Active Comparator | Pregabalin administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADL5747 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period) | The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. | Baseline, Week 2 of Treatment Period 1 or 2 |
Not provided
Not provided
Key inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wei Du, MD | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laszlo J. Mate, MD | West Palm Beach | Florida | 33407-2450 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: Placebo Then Pregabalin | Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1. A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID. Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pregabalin | Drug |
|
|
| FG001 | Treatment Sequence 2: Pregabalin Then Placebo | Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days. Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2. At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week. |
| FG002 | Treatment Sequence 3: Placebo Then ADL5747 | Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1. A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID. During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days. At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week |
| FG003 | Treatment Sequence 4: ADL5747 Then Placebo | During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days. A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID. Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2. At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout Period |
|
| Treatment Period 2 |
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: Placebo Then Pregabalin | Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period. |
| BG001 | Treatment Sequence 2: Pregabalin Then Placebo | Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period. Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. |
| BG002 | Treatment Sequence 3: Placebo Then ADL5747 | Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. |
| BG003 | Treatment Sequence 4: ADL5747 Then Placebo | ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods. Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Change in Weekly Average Numeric Pain Rating Scale (NPRS) Score From Baseline to End of Treatment (Week 2 of Each Treatment Period) | The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. The mean of the daily average scores were calculated from the NPRS pain assessments obtained up to 3 times per day over a 7-day period. | Zero participants were analyzed, and no data was collected for this measure. Due to lack of efficacy of ADL5747, the study was terminated early. | Posted | Baseline, Week 2 of Treatment Period 1 or 2 |
|
|
Not provided
Adverse events are summarized by study drug for participants who received at least 1 dose of that study drug. For example, 9 participants from Treatment Sequence (TS) 4 received at least 1 dose of ADL5747 in Treatment Period (TP) 1, and 9 participants from TS 3 received at least 1 dose ADL5747 in TP 2. Therefore, 18 participants received ADL5747.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADL5747 | ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods. | 0 | 18 | 4 | 18 | ||
| EG001 | Placebo | Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods. Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2. | 0 | 38 | 7 | 38 | ||
| EG002 | Pregabalin | Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period. | 0 | 19 | 9 | 19 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Gait Disturbance | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Somnolence | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Euphoric mood | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Balance disorder | Nervous system disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysarthria | Psychiatric disorders | Systematic Assessment |
| ||
| Edema peripheral | Cardiac disorders | Systematic Assessment |
| ||
| Feeling jittery | General disorders | Systematic Assessment |
| ||
| Hypoesthesia | General disorders | Systematic Assessment |
| ||
| Hypoesthesia oral | General disorders | Systematic Assessment |
| ||
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nystagmus | Eye disorders | Systematic Assessment |
| ||
| Paresthesia | General disorders | Systematic Assessment |
| ||
| Speech disorder | Nervous system disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Urine analysis abnormal | Renal and urinary disorders | Systematic Assessment |
| ||
| Weight decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
On the basis of the interim analysis, the results indicated that ADL5747 did not show sufficient efficacy to continue the study; therefore, formal and final efficacy analyses were not generated for this study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals | (781) 860-8660 |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C544196 | N,N-diethyl-3-hydroxy-4-(spiro(chromene-2,4'-piperidine)-4-yl)benzamide |
| 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
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|