Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy

NCT02339428 | Completed Phase 3

• 1 other identifier: UHRijeka-diclo-colono
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

Colonoscopy; diagnostic; diclophenac; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Reduction of total mean pain index (as measured on a 10-point Likert scale)

  Patients will be followed until hospital discharge, an average of 10 days.

Secondary Outcomes (5)

• 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)

  Patients will be followed until hospital discharge, an average of 10 days.

• 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)

  Patients will be followed until hospital discharge, an average of 10 days.

• Proportion of patients that are willing to repeat the procedure, if necessary

  Patients will be followed until hospital discharge, an average of 10 days.

• Need for sedation or analgesia during colonoscopy

  Patients will be followed until hospital discharge, an average of 10 days.

• Time to discharge

  Patients will be followed until hospital discharge, an average of 10 days.

Other Outcomes (1)

• Adverse events

  Patients will be followed until hospital discharge, an average of 10 days.

Study Arms (2)

Diclophenac sodium 100mg p.o.

EXPERIMENTAL

Patients will be given 100mg of diclophenac sodium two hours prior to colonoscopy.

Drug: diclophenac sodium

Placebo

PLACEBO COMPARATOR

Patients will be given placebo tablets of same appearance as the intervention.

Drug: Placebo

Interventions

diclophenac sodium DRUG

Patients will be given 100mg p.o. diclophenac sodium tablets

Also known as: diclophenac

Diclophenac sodium 100mg p.o.

Placebo DRUG

Inactive pill manufactured to mimic diclofenac tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Rijeka: lead

Study Sites (1)

University Hospital Center Rijeka

Rijeka, Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Anemia; Disease

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Vanja Giljaca, MD, PhD

  University Hospital Center Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vanja Giljaca, MD, PhD

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 15, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

CR (1)