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The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy.
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The purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo as an adjunct to standard of care |
|
| Pregabalin | Active Comparator | Pregabalin as an adjunct to standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo as an adjunct to standard of care |
| |
| Pregabalin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain on Movement Score | Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain. | Every 12 hours from Day 1 to Day 5 post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Pain Score | Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | Day 1 to Day 7, Day 8 to Day 14 post-surgery |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 033 | India | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days. |
| FG001 | Placebo | Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
75 mg BD for 14 days |
|
| Mean Daily Sleep Interference Score | Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | Day 1 to Day 5 post-surgery |
| Mean Anxiety Visual Analogue Scale (A-VAS) | Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious. | Day 0 to Day 5 post-surgery |
| Time to Mobilization After Surgery | Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization. | Day 1 to Day 5 post-surgery |
| Number of Participants With Rescue Medication Usage | Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications. | Day 0 to Day 6 post-surgery |
| Number of Participants With Neuropathic Pain | ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. "Yes" response to questions 1-5 were scored as 1, while a "yes" response to question 6 was scored as -1. "No" response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported. | Day 90, Day 180 post-surgery |
| Ahmedabad |
| Gujarat |
| 380 015 |
| India |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 076 | India |
| Pfizer Investigational Site | Kanpur | Uttar Pradesh | 208 001 | India |
| Pfizer Investigational Site | Kanpur | Uttar Pradesh | 208 002 | India |
| Pfizer Investigational Site | Kolkata | West Bengal | 700 054 | India |
| Pfizer Investigational Site | New Delhi | 110 017 | India |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days. |
| BG001 | Placebo | Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days. |
| 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 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Pain on Movement Score | Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain. | Modified Intent to Treat (MITT) population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Error | Units on a scale | Every 12 hours from Day 1 to Day 5 post-surgery |
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| Secondary | Mean Daily Pain Score | Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. | MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. 'n' signifies participants who were evaluable for this measure at specified time-point for each arm. | Posted | Mean | Standard Error | Units on a scale | Day 1 to Day 7, Day 8 to Day 14 post-surgery |
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| Secondary | Mean Daily Sleep Interference Score | Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. | MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Error | Units on a scale | Day 1 to Day 5 post-surgery |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Anxiety Visual Analogue Scale (A-VAS) | Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious. | MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Mean | Standard Error | Units on a scale | Day 0 to Day 5 post-surgery |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Mobilization After Surgery | Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization. | MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | Posted | Median | Inter-Quartile Range | hours | Day 1 to Day 5 post-surgery |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Rescue Medication Usage | Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications. | MITT population included all randomized participants who had at least taken pre-surgery study medication and had no surgical complications. | Posted | Number | participants | Day 0 to Day 6 post-surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Neuropathic Pain | ID Pain questionnaire was used to assess neuropathic pain. 6 items questionnaire, did pain feel like: (1)pins and needles (2)hot/burning (3)numb (4)electrical shocks (5)is pain made worse with touch of clothing or bed sheets (6)is pain limited to your joints. "Yes" response to questions 1-5 were scored as 1, while a "yes" response to question 6 was scored as -1. "No" response were scored as 0. Overall score range -1 to 5.Higher score more indicative of pain with a neuropathic component. Number of participants with score 2 or more (which indicated nerve pain) were reported. | Data was not analyzed as the intended sample size was not met, and the reported numbers from the final set were not sufficient for a meaningful analysis. | Posted | Day 90, Day 180 post-surgery |
|
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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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days. | 2 | 35 | 23 | 35 | ||
| EG001 | Placebo | Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days. | 0 | 37 | 22 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen saturation decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Orchitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Urinary retention postoperative | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bladder disorder | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bladder pain | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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As the enrollment rate was very low, the study was prematurely terminated. The number of enrolled participants was too low for meaningful formal statistical conclusions.
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 |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| 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 |
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