Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study
This study is currently recruiting participants.
Verified January 2013 by Parc de Salut Mar
Sponsor:
Parc de Salut Mar
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01768988
First received: January 14, 2013
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer. |
Drug: Placebo Drug: Pregabalin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study |
Resource links provided by NLM:
Further study details as provided by Parc de Salut Mar:
Primary Outcome Measures:
- Pregabalin Therapy [ Time Frame: From baseline to day 90. ] [ Designated as safety issue: Yes ]Analgesic effect of pregabalin therapy in pancreatic cancer patients, assessed using a visual analogue scale (VAS), the Brief Pain Inventory (BPI) and Neuropathic Pain Symptom Inventory (NPSI).
Secondary Outcome Measures:
- Quality of life [ Time Frame: From baseline to day 90. ] [ Designated as safety issue: Yes ]Changes in quality of life compared to baseline level using SF-12 (Short-Form Health Survey) quality of life questionnaire.
- Performance status [ Time Frame: From baseline until to day 90. ] [ Designated as safety issue: Yes ]Performance status (Karnofsky Performance Status Scale).
- Anxiety and depression [ Time Frame: From baseline to day 90. ] [ Designated as safety issue: Yes ]Anxiety and depression will be also assessed, using Hospital Anxiety and Depression Scale (HADS).
| Estimated Enrollment: | 72 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group I
Conventional analgesic treatment + pregabalin.
|
Drug: Pregabalin
Treatment during 90 days with pregabalin.
|
|
Placebo Comparator: Group II
Conventional analgesic treatment + placebo.
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 1. Patients > 18 years old recently diagnosed of pancreatic cancer (<3 months).
- 2. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- 3. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Exclusion Criteria:
- 1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- 2. Patients with previously diagnosed moderate to severe renal impairment. Those with a Clearance of Creatinine (CLcr) < 60mL/min should be excluded.
- 3. Patients treated with anticonvulsants during the previous 4 months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768988
Contacts
| Contact: Dürsteler Christian, PhD | 0034 93 2483350 | cdursteler@parcdesalutmar.cat |
Locations
| Spain | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain, 08003 | |
| Contact: Dürsteler Christian, PhD 0034 93 2483350 cdursteler@parcdesalutmar.cat | |
Sponsors and Collaborators
Parc de Salut Mar
More Information
No publications provided
| Responsible Party: | Parc de Salut Mar |
| ClinicalTrials.gov Identifier: | NCT01768988 History of Changes |
| Other Study ID Numbers: | PANPAIN/1 |
| Study First Received: | January 14, 2013 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on June 18, 2013