Not provided
Not provided
Not provided
Not provided
Not provided
See detailed description for termination reason
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.
This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | flexible dosing |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 150- 600 mg/day (double blind in divided doses) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days). | Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | St Leonards | New South Wales | 2065 | Australia | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Of the 69 subjects screened, 64 were randomized, and 61 received treatment. Of the 8 subjects screened but not treated, 1 was ineligible due to an abnormal laboratory test result, 6 were ineligible due to a reason categorized as other, and 1 was no longer willing to continue in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
|
| Baseline to Cycle 9 |
| Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). | Baseline to Cycle 9, LOCF cycle endpoint |
| Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). | Baseline to Cycle 9, LOCF cycle endpoint |
| Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours. | Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint |
| Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime. | Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Pfizer Investigational Site | Bielefeld | 33611 | Germany |
| Pfizer Investigational Site | Essen | 45122 | Germany |
| Pfizer Investigational Site | Hamm | 59071 | Germany |
| Pfizer Investigational Site | Chieti Scalo | 66013 | Italy |
| Pfizer Investigational Site | Potenza | 85100 | Italy |
| Pfizer Investigational Site | Goyang-si | Gyeonggi-do | 411-769 | South Korea |
| Pfizer Investigational Site | Seoul | 130-702 | South Korea |
| Pfizer Investigational Site | Seoul | 137-701 | South Korea |
| Pfizer Investigational Site | Santander | Cantabria | 39008 | Spain |
| Pfizer Investigational Site | Alicante | 03010 | Spain |
| Pfizer Investigational Site | Jaén | 23007 | Spain |
| Pfizer Investigational Site | Niao-Sung Hsiang | Kaohsiung Hsien | Taiwan |
| Pfizer Investigational Site | Taipei | 10449 | Taiwan |
| Placebo |
matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). |
| BG001 | Placebo | matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). |
| 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 |
| |||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). | Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to Cycle 9 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). | ITT population, subjects with at lest 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to Cycle 9, LOCF cycle endpoint |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). | ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to Cycle 9, LOCF cycle endpoint |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle | Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours. | ITT population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained. | Posted | Least Squares Mean | Standard Error | score on scale | Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms | Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime. | ITT population, subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained. | Posted | Number | participants | Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS) | Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days). | Intent-to-Treat (ITT) population: subjects with at least 1 dose of study medication and for whom at least 1 post-baseline efficacy evaluation was obtained; Last Observation Carried Forward (LOCF): last recorded cycle. Primary analysis timeframe: 10 days of paresthesia scores from the onset of chemotherapy to the last cycle of chemotherapy (LOCF). | Posted | Least Squares Mean | Standard Error | score on scale | Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF) |
|
Not provided
Not provided
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 | Pregabalin | Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID). | 5 | 32 | 31 | 32 | ||
| EG001 | Placebo | matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). | 7 | 29 | 27 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedRA (v11.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Ileus paralytic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Disease progression | General disorders | Systematic Assessment |
| ||
| Extravasation | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Peritoneal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Shock | Vascular disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Dermoid cyst | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Eye irritation | Eye disorders | Systematic Assessment |
| ||
| Lacrimation increased | Eye disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faecaloma | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Paraesthesia oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal tenesmus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Eye disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Feeling cold | General disorders | Systematic Assessment |
| ||
| Implant site pain | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Peripheral coldness | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
| ||
| Allergy to arthropod sting | Immune system disorders | Systematic Assessment |
| ||
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| Herpes virus infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Anastomotic ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood creatine increased | Investigations | Systematic Assessment |
| ||
| Body temperature increased | Investigations | Systematic Assessment |
| ||
| Platelet count | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neckpain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Amnesia | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysaethesia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hyperaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Polyneuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Syncope vasovagal | Nervous system disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Balanitis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Nail discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin discolouration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Circulatory collapse | Vascular disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Subclavian vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
Due to lack of symptom emergence, enrollment was halted, and endpoint modified because primary assumptions upon which it was powered (emergence of symptomatology) were not met, and not all endpoints were able to be reliably analyzed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D004358 | Drug Therapy |
| 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 |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Cycle 3 (n=24, 23) |
|
| Cycle 4 (n=25, 23) |
|
| Cycle 5 (n=24, 22) |
|
| Cycle 6 (n=21, 21) |
|
| Cycle 7 (n=17, 22) |
|
| Cycle 8 (n=16, 19) |
|
| Cycle 9 (n=16, 18) |
|
LS means and corresponding standard errors derived from ANCOVA model were used.
| Superiority or Other (legacy) |
| Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.5757 | No multiple comparisons adjustment was made. | Mean Difference (Final Values) | 0.13 | Standard Error of the Mean | 0.23 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.6065 | No multiple comparisons adjustment was made. | Mean Difference (Final Values) | 0.15 | Standard Error of the Mean | 0.30 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.4301 | No multiple comparisons adjustment was made. | Mean Difference (Final Values) | 0.24 | Standard Error of the Mean | 0.31 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.3125 | No multiple comparisons adjustment was made. | Mean Difference (Final Values) | 0.50 | Standard Error of the Mean | 0.49 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.8169 | No multiple comparisons adjustment was made. | Mean Difference (Final Values) | 0.09 | Standard Error of the Mean | 0.41 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.9359 | Mean Difference (Final Values) | -0.03 | Standard Error of the Mean | 0.40 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.6233 | Mean Difference (Final Values) | -0.20 | Standard Error of the Mean | 0.40 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence. | ANCOVA | Model terms include treatment, study center, and baseline score. | 0.1569 | No multiple comparisons adjustment was made. | Mean Difference (Final Values) | -0.73 | Standard Error of the Mean | 0.50 | LS means and corresponding standard errors derived from ANCOVA model were used. | Superiority or Other (legacy) |
| Units | Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|