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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 September 2015 |
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Main ID: |
NCT01528540 |
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Date of registration:
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27/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial
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Scientific title:
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Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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87 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01528540 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Rupjyoti Talukdar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asian Institue of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Epigastric pain +/- radiation at least thrice in one month over the past three
month.
2. Endotherapy/Surgery and ducal clearance
Exclusion Criteria:
1. Age <18 and >65yrs
2. MPD and biliary obstruction
3. Pancreatic neoplastic lesions
4. Acute flare
5. Pancreatic pseudocysts
6. Pregnancy
7. Cardiac and renal diseases
8. Use of other anti epileptics
9. Hypersensitivity to gabapentin/pregabalin
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Pancreatitis
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Intervention(s)
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Drug: Antioxidant plus Pregabalin
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Drug: Placebo
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Primary Outcome(s)
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Change in the pain score
[Time Frame: Baseline and 8weeks]
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Secondary Outcome(s)
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Change in number of painful days
[Time Frame: Baseline and 8weeks]
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Change in depression scale
[Time Frame: Baseline and 8weeks]
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Change in quality of life
[Time Frame: Baseline and 8weeks]
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Change in analgesic requirement
[Time Frame: Baseline and 8weeks]
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Secondary ID(s)
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AIG-PAN-2012-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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