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This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. It will also examine other measures of next-day performance and next-day sleepiness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
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| Arm B | Experimental |
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| Arm C | Active Comparator |
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| Arm D | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 250 mg, oral, prior to bedtime on the night before performance testing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) | Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive. | 7.25 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Speed Deviation | Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Standard deviation of speed was reported in the outcome measure. |
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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 |
|---|---|---|---|---|---|---|
| Baptist Sleep Centers, LLP | South Miami | Florida | 33143 | United States | ||
| Miami Research Associates |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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Prior to randomization, all participants were screened for simulator sickness and underwent standardized training on the driving simulator to ensure that participants fully understood how to perform the tests, were comfortable, and attained a stable level of performance on the various performance-based measures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diphenhydramine Citrate, Gabapentin, Placebo, Triazolam | A single dose of 1 diphenhydramine citrate 76 milligram (mg) capsule and 2 placebo tablets orally in first intervention period followed by a single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in second intervention period, then a single dose of 1 placebo capsule and 2 placebo tablets orally in third intervention period and then a single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention Period |
|
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| Diphenhydramine citrate |
| Drug |
76 mg, oral, prior to bedtime on the night before performance testing |
|
| Triazolam | Drug | 0.5 mg, oral, prior to bedtime on the night before performance testing |
|
| Placebo | Drug | Oral, prior to bedtime on the night before performance testing |
|
| 7.25 hours post dose |
| Lane Exceedance | Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Mean lanes excursed/exceeded was reported in the outcome measure. | 7.25 hours post-dose |
| South Miami |
| Florida |
| 33143 |
| United States |
| NeuroTrials Research Sleep Lab | Atlanta | Georgia | 30342 | United States |
| NeuroTrials Research, Inc. | Atlanta | Georgia | 30342 | United States |
| FG001 | Gabapentin, Triazolam, Diphenhydramine Citrate, Placebo | A single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in first intervention period followed by a single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in second intervention period then a single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in third intervention period and then a single dose of 1 placebo capsule and 2 placebo tablets orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period. |
| FG002 | Triazolam, Placebo, Gabapentin, Diphenhydramine Citrate | A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in first intervention period followed by 1 placebo capsule and 2 placebo tablets orally in second intervention period then a single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in third intervention period and then a single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period. |
| FG003 | Placebo, Diphenhydramine Citrate, Triazolam, Gabapentin | A single dose of 1 placebo capsule and 2 placebo tablets orally in first intervention period followed by a single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in second intervention period then a single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in third intervention period and then a single dose of gabapentin 250 mg capsule and 2 placebo tablets orally in fourth intervention period. Each intervention period consisted of dosing day on which the study treatment was administered at night followed by testing day. A washout period of 7 to 14 days was maintained between each intervention period. |
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| NOT COMPLETED |
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| Washout Period 1 |
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| Second Intervention Period |
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| Washout Period 2 |
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| Third Intervention Period |
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| Washout Period 3 |
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| Fourth Intervention Period |
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Intent to Treat (ITT) population included all randomized participants who received at least 1 dose of investigational product and provided any data post-randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All participants randomized to receive diphenhydramine citrate first, gabapentin first, triazolam first or placebo first. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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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 | Standard Deviation of Lateral Position (SDLP) | Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive. | ITT population included all randomized participants who received at least 1 dose of investigational product and provided any data post-randomization. | Posted | Mean | Standard Deviation | centimeter (cm) | 7.25 hours post-dose |
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| Secondary | Speed Deviation | Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Standard deviation of speed was reported in the outcome measure. | ITT population included all randomized participants who received at least 1 dose of investigational product and provided any data post-randomization. | Posted | Mean | Standard Deviation | meters per second (m/sec) | 7.25 hours post dose |
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| Secondary | Lane Exceedance | Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Mean lanes excursed/exceeded was reported in the outcome measure. | ITT population included all randomized participants who received at least 1 dose of investigational product and provided any data post-randomization. | Posted | Mean | Standard Deviation | lanes exceeded | 7.25 hours post-dose |
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Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as nonserious in another participant or 1 participant may have experienced both serious and nonserious event during study. Safety population was evaluated.
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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 | Placebo | A single dose of 1 placebo capsule and 2 placebo tablets orally in one of the four intervention periods. | 0 | 58 | 3 | 58 | ||
| EG001 | Gabapentin | A single dose of 1 gabapentin 250 mg capsule and 2 placebo tablets orally in one of the four intervention periods. | 0 | 55 | 2 | 55 | ||
| EG002 | Diphenhydramine Citrate | A single dose of 1 diphenhydramine citrate 76 mg capsule and 2 placebo tablets orally in one of the four intervention periods. | 0 | 57 | 3 | 57 | ||
| EG003 | Triazolam | A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in one of the four intervention periods. | 0 | 56 | 10 | 56 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
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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 |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D004155 | Diphenhydramine |
| D014229 | Triazolam |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Withdrawal by Subject |
|
| For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant. | Hodges-Lehman estimate | 0.55 | 2-Sided | 95 | -0.66 | 2.33 | Hodges-Lehman estimate of treatment difference was reported. | Non-Inferiority or Equivalence (legacy) | For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95 percent (%) confidence interval (CI) was 2.4 cm. |
| For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant. | Wilcoxon Rank Sum test | 0.134 | Statistical comparison was performed at a two-sided significance level of 0.05. | Hodges-Lehman estimate | 1.02 | 2-Sided | 95 | -0.39 | 2.51 | Hodges-Lehman estimate of treatment difference was reported. | Superiority or Other (legacy) |
| For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant. | Wilcoxon Rank Sum test | <0.001 | Statistical comparison was performed at a two-sided significance level of 0.05. | Hodges-Lehman estimate | 2.37 | 2-Sided | 95 | 1.01 | 3.98 | Hodges-Lehman estimate of treatment difference was reported. | Superiority or Other (legacy) |
| Triazolam |
A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in one of the four intervention periods. |
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| Triazolam |
A single dose of 2 triazolam 0.25 mg tablets (equivalent to triazolam 0.5 mg) and 1 placebo capsule orally in one of the four intervention periods. |
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