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Trial record 10 of 453 for:    DICLOFENAC

Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339428
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Vanja Giljaca, University Hospital Rijeka

Brief Summary:
Patients will be randomized to receive diclophenac sodium or placebo two hours before diagnostic colonoscopy. Intensity of pain as measured on a 10-point Likert scale will be the primary outcome. Patients will be followed until hospital discharge, an average of 10 days.

Condition or disease Intervention/treatment Phase
Anemia Drug: diclophenac sodium Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy: a Randomized Controlled Study
Study Start Date : January 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Diclophenac sodium 100mg p.o.
Patients will be given 100mg of diclophenac sodium two hours prior to colonoscopy.
Drug: diclophenac sodium
Patients will be given 100mg p.o. diclophenac sodium tablets
Other Name: diclophenac

Placebo Comparator: Placebo
Patients will be given placebo tablets of same appearance as the intervention.
Drug: Placebo
Inactive pill manufactured to mimic diclofenac tablet




Primary Outcome Measures :
  1. Reduction of total mean pain index (as measured on a 10-point Likert scale) [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]

Secondary Outcome Measures :
  1. Reduction of pain in the subgroup of patients with high pain index (defined as patients that report 7-10, inclusive, on a 10-point Likert scale) [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]
  2. Reduction of pain in the subgroup of patients with moderate pain index (defined as patients that report 3-6, inclusive, on a 10-point Likert scale) [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]
  3. Proportion of patients that are willing to repeat the procedure, if necessary [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]
  4. Need for sedation or analgesia during colonoscopy [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]
  5. Time to discharge [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: Patients will be followed until hospital discharge, an average of 10 days. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all inpatients that are referred for colonoscopy for any indication during their hospital stay.

Exclusion Criteria:

  • refusal to sign informed consent
  • age <18 years
  • pregnancy
  • lactation
  • allergy to any nonsteroidal antiinflammatory drug
  • patients that have taken any nonsteroidal antiinflammatory drug in the previous seven days before
  • randomisation (except acetylsalicylic acid in doses up to 300 mg/day)
  • patients on antiplatelet or anticoagulation therapy (except acetylsalicylic acid in doses up to 300 mg/day)
  • history of gastric or duodenal ulcer
  • history of GI bleeding or perforation
  • history of or active inflammatory bowel disease
  • severe liver disease (defined as presence of history of ascites and/or esophageal varices)
  • severe kidney disease (defined as glomerular filtration rate <30 ml/min)
  • history of myocardial infarction or cerebrovascular disease
  • history of peripheral arterial disease
  • congestive heart failure (NYHA III-IV)
  • history of systemic lupus erythematosus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339428


Locations
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Croatia
University Hospital Center Rijeka
Rijeka, Croatia, 51000
Sponsors and Collaborators
University Hospital Rijeka
Investigators
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Principal Investigator: Vanja Giljaca, MD, PhD University Hospital Center Rijeka

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Responsible Party: Vanja Giljaca, Vanja Giljaca, MD, PhD, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT02339428     History of Changes
Other Study ID Numbers: UHRijeka-diclo-colono
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by Vanja Giljaca, University Hospital Rijeka:
Colonoscopy
diagnostic
diclophenac
randomized controlled trial
Additional relevant MeSH terms:
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Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action