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Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.
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This is a randomized, double blind controlled, parallel arms trial, aimed to assess the efficacy of pregabalin on pancreatic cancer induced abdominal pain. The goals of this study include (1) assessing the analgesic effect of pregabalin in comparison to placebo; assessing the presence of central sensitization and its potential reversion by Pregabalin; (3) assessing quality of life of patients treated with pregabalin in comparison to placebo; (4) to compare adverse effects in patients treated with Pregabalin in comparison to placebo; (5) to compare anxiety and depression in patients treated with pregabalin in comparison to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Conventional analgesic treatment + pregabalin. |
|
| Group II | Placebo Comparator | Conventional analgesic treatment + placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Conventional treatment + placebo (during 90 days). Conventional treatment comprises a WHO step ladder approach and comprises in most cases:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity (Visual Analogue Scale; VAS Score) | Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain VAS score. | From baseline to day 90. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Changes in quality of life compared to baseline level using SF-36 (Short-Form Health Survey) quality of life questionnaire. | From baseline to day 90. |
| Performance status | Performance status (Karnofsky Performance Status Scale). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | 08003 | Spain |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Pregabalin | Drug | Treatment during 90 days with conventional treatment + pregabalin. Pregabalin doses were reached until the maximal doses (300 mg/12h) depending on patient tolerability. An escalating dose scheme were desigened as follows, to avoid tolerability problems: Week 1 75-0-75 Week 2 75-0-150 Week 3 150-0-150 Week 4 150-0-300 Week 5 300-0-300 (until the end of study) Conventional treatment comprises a WHO step ladder approach and comprises in most cases:
|
|
| From baseline until to day 90. |
| Anxiety and depression | Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS). | From baseline to day 90. |
| Neuropathic Pain | Neuropathic pain participation will be measured by a neuropathic pain questionnaire (NPSI). | From baseline to day 90. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D059226 | Nociceptive Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |