search
Back to results

The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain

Primary Purpose

Postsurgical Pain, Abdominal Pain, Chronic Pain

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Tetrahydrocannabinol
Placebo
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postsurgical Pain focused on measuring postsurgical pain, abdominal pain, visceral pain, chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18 years or older
  • Pain should have developed after a surgical procedure
  • Pain duration exceeding 3 months, and average NRS≥3
  • Stable doses intake of analgesics for the past 2 months
  • The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion Criteria:

  • Diagnosed irritated bowel syndrome (IBS) or chronic pancreatitis
  • Patient took cannabinoids on a regular basis for at least one year
  • Patient does not feel a pinprick test in the lower extremities
  • Patient has a body mass index (BMI) above 36,0 kg/m2
  • Patient suffers from serious painful conditions other than chronic pancreatitis
  • Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
  • Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
  • Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
  • Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
  • Patient has an actual moderate to severe renal impairment
  • Patient has an actual moderate to severe hepatic impairment
  • Patient has a presence or history of major psychiatric illness
  • Patient has experienced an epileptic seizure in the past
  • Patient demonstrates clinically significant laboratory abnormalities
  • Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
  • Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
  • Patient has a history of sensitivity / idiosyncrasy to THC
  • Patient has a known or suspected lactose intolerance
  • Female patient is pregnant or breastfeeding
  • Patient intends to conceive a child during the course of the study
  • Patient participates in another investigational drug study
  • Patient has a clinical significant exacerbation in illness
  • Patient is unwilling or unable to comply with the lifestyle guidelines

Sites / Locations

  • Radboud University Nijmegen Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

delta-9-tetrahydrocannabinol (namisol)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Average VAS pain
The primary outcome measure is defined as the reduction in average VAS pain scores at the end of the study (day 50-52) compared to the pre-treatment level between the Namisol® and placebo group, measured by a Visual Analoge Scale (VAS) in a pain diary.

Secondary Outcome Measures

Electroencephalogram (EEG)
Evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and spontaneous brain activity will be measured in the electroencephalogram (EEG).
Quantitative Sensory Testing (QST)
Pressure pain thresholds, electrical thresholds, electric wind-up response, and Diffuse Noxious Inhibitory Control (DNIC) will be measured using Quantitative Sensory Testing (QST).
Depression and (pain related) anxiety
Depression and (pain related) anxiety measured by questionnaires.
Pharmacodynamic parameters
Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
Safety parameters
Laboratory Electrocardiogram (ECG) Heart Frequency (HF) / Blood Pressure (BP) Adverse Events (AE)
Quality of life
Quality of life will be evaluated by questionnaires

Full Information

First Posted
March 7, 2012
Last Updated
October 27, 2014
Sponsor
Radboud University Medical Center
Collaborators
European Union
search

1. Study Identification

Unique Protocol Identification Number
NCT01562483
Brief Title
The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain
Official Title
The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain; a Randomized, Double Blinded, Placebo-controlled, Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
European Union

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain, Abdominal Pain, Chronic Pain
Keywords
postsurgical pain, abdominal pain, visceral pain, chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
delta-9-tetrahydrocannabinol (namisol)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tetrahydrocannabinol
Other Intervention Name(s)
Namisol, Dronabinol
Intervention Description
The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical to the Namisol arm.
Primary Outcome Measure Information:
Title
Average VAS pain
Description
The primary outcome measure is defined as the reduction in average VAS pain scores at the end of the study (day 50-52) compared to the pre-treatment level between the Namisol® and placebo group, measured by a Visual Analoge Scale (VAS) in a pain diary.
Time Frame
Baseline versus day 52
Secondary Outcome Measure Information:
Title
Electroencephalogram (EEG)
Description
Evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and spontaneous brain activity will be measured in the electroencephalogram (EEG).
Time Frame
Baseline versus day 52
Title
Quantitative Sensory Testing (QST)
Description
Pressure pain thresholds, electrical thresholds, electric wind-up response, and Diffuse Noxious Inhibitory Control (DNIC) will be measured using Quantitative Sensory Testing (QST).
Time Frame
Baseline versus day 15 and day 52
Title
Depression and (pain related) anxiety
Description
Depression and (pain related) anxiety measured by questionnaires.
Time Frame
Baseline versus day 52
Title
Pharmacodynamic parameters
Description
Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
Time Frame
Baseline versus day 15 and day 52
Title
Safety parameters
Description
Laboratory Electrocardiogram (ECG) Heart Frequency (HF) / Blood Pressure (BP) Adverse Events (AE)
Time Frame
Baseline until follow-up (day 59-61)
Title
Quality of life
Description
Quality of life will be evaluated by questionnaires
Time Frame
Baseline versus day 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 years or older Pain should have developed after a surgical procedure Pain duration exceeding 3 months, and average NRS≥3 Stable doses intake of analgesics for the past 2 months The patient has been informed about the study, understood the information and signed the informed consent form Exclusion Criteria: Diagnosed irritated bowel syndrome (IBS) or chronic pancreatitis Patient took cannabinoids on a regular basis for at least one year Patient does not feel a pinprick test in the lower extremities Patient has a body mass index (BMI) above 36,0 kg/m2 Patient suffers from serious painful conditions other than chronic pancreatitis Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG) Patient has an actual moderate to severe renal impairment Patient has an actual moderate to severe hepatic impairment Patient has a presence or history of major psychiatric illness Patient has experienced an epileptic seizure in the past Patient demonstrates clinically significant laboratory abnormalities Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test Patient has a history of sensitivity / idiosyncrasy to THC Patient has a known or suspected lactose intolerance Female patient is pregnant or breastfeeding Patient intends to conceive a child during the course of the study Patient participates in another investigational drug study Patient has a clinical significant exacerbation in illness Patient is unwilling or unable to comply with the lifestyle guidelines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry van Goor, MD, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Centre, department of surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
27720917
Citation
de Vries M, van Rijckevorsel DCM, Vissers KCP, Wilder-Smith OHG, van Goor H; Pain and Nociception Neuroscience Research Group. Tetrahydrocannabinol Does Not Reduce Pain in Patients With Chronic Abdominal Pain in a Phase 2 Placebo-controlled Study. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1079-1086.e4. doi: 10.1016/j.cgh.2016.09.147. Epub 2016 Oct 5.
Results Reference
derived

Learn more about this trial

The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain

We'll reach out to this number within 24 hrs