The Influence of Tramadol on Opioid-induced Bowel Dysfunction

NCT06385561 | Completed Phase 2

• 2 other identifiers: Tramadol_OIBD2022-500108-23-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers.

Conditions

Opioid-Induced Bowel Dysfunction; Constipation

Outcome Measures

Primary Outcomes (2)

• Total gastrointestinal transit time

  Difference in hours from ingestion of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment

  From day 4 to day 8

• Colorectal transit time

  Difference in hours from the entering in the colon of a 3D Transit Capsule to expulsion of the capsule during active and placebo treatment

  From day 4 to day 8

Secondary Outcomes (15)

• Constipation symptoms

  From day 1 to day 10

• Bowel movement frequency

  From day 1 to day 10

• Stool consistency

  From day 1 to day 10

• Gastrointestinal symptoms

  Day 1 and day 10

• Opioid-induced constipation

  Day 1 and day 10

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Tramadol

Drug: Tramadol

Placebo treatment

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Tramadol DRUG

Tramadol is administered orally twice daily in a dosage of 100 mg (daily total of 200 mg)

Active treatment

Placebo DRUG

Placebo is administered orally twice daily.

Placebo treatment

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (assessed by a study-affiliated medical doctor.)
• Signed informed consent.
• Able to read and understand Danish.
• Male (to avoid influence of menstrual cycles)
• Northern European descent (to minimize genetic variance influences on drug metabolism).
• The researcher believes that the participant understands the study details, is compliant and is expected to complete the study.
• Opioid naïve\* (who have not taken prescription opioid for one week or longer and at least a year have passed since completion of a previous opioid study.)
• Between 20 and 40 years of age.

You may not qualify if:

• Known hypersensitivity or allergy towards the used pharmaceutical compounds or pharmaceutical compounds similar to those used in the study.
• Less than three spontaneous bowel movements per week.
• Participation in other studies within 14 days prior to first visit.
• Expected need of medical/surgical treatment during the study.
• Any diagnosed disease, which investigator concludes will affect the trial (including all contraindicated complications: severe chronic obstructive pulmonary disease, pulmonary heart disease, severe bronchial asthma, paralytic ileus, hypercapnia, serious respiratory depression with hypoxia, moderate to severe decreased liver function, gastrointestinal obstruction or perforation, acute surgical abdominal complications such as appendicitis, Mb. Crohn's, ulcerative colitis, and toxic mega colon).
• History of substance abuse (alcohol, tetrahydrocannabinol (THC), benzodiazepine, central stimulants and/or opioids, urine drug test will be performed prior to treatment start). ¹
• History of major mental disorders (e.g., major anxiety, major depression or treatment with psychoactive medications etc.) ²
• Metal implants or pacemaker.
• Daily use of prescription only medicine
• Daily alcohol consumption
• Participation motivated by "wrongful" reasons such as poor economy, or psychosocial issues e.g., problems in the family, loneliness, sadness. People with such problems may be more likely to develop substance dependence.1
• Intake of alcohol within 48 hours before start of study period or any alcohol consumption during each study period. If consumption takes place during the study the participant will be excluded.
• Use of any analgesic medication within 48 hours before start as well as for the duration of the study. If consumption takes place during the study the participant will be excluded.
• Nicotine use

Sponsors & Collaborators

• Asbjørn Mohr Drewes: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 26, 2024
• Study Start: August 11, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)