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Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

Primary Purpose

Pancreatitis, Chronic, 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 Pancreatitis, Chronic focused on measuring chronic pancreatitis, 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
  • Confirmed chronic pancreatitis
  • 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:

  • 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 32,0 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 daily pain diary.

Secondary Outcome Measures

EEG
Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.
QST
Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.
Safety
Laboratory ECG HF / BP Adverse events
Pharmacokinetics
THC, 11-OH-THC and THC-COOH concentrations
Functional parameters
Body weight Supplementary feeding
Quality of life
Quality of life will be evaluated by questionnaires
Pharmacodynamics
Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)

Full Information

First Posted
February 7, 2012
Last Updated
October 27, 2014
Sponsor
Radboud University Medical Center
Collaborators
European Union
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1. Study Identification

Unique Protocol Identification Number
NCT01551511
Brief Title
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
Official Title
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design
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
Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Chronic, Abdominal Pain, Chronic Pain
Keywords
chronic pancreatitis, 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
29 (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 step-up approach 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 daily pain diary.
Time Frame
Baseline versus day 52
Secondary Outcome Measure Information:
Title
EEG
Description
Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.
Time Frame
Baseline and day 52
Title
QST
Description
Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.
Time Frame
Baseline versus day 15 and day 52
Title
Safety
Description
Laboratory ECG HF / BP Adverse events
Time Frame
Baseline until follow-up (day 59-61)
Title
Pharmacokinetics
Description
THC, 11-OH-THC and THC-COOH concentrations
Time Frame
Predose levels at baseline, day 15 and day 52; postdose levels (30 min, 45 min, 60 min, 100 min) at day 15 and 52
Title
Functional parameters
Description
Body weight Supplementary feeding
Time Frame
Baseline until day 52
Title
Quality of life
Description
Quality of life will be evaluated by questionnaires
Time Frame
Baseline versus day 52
Title
Pharmacodynamics
Description
Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
Time Frame
Baseline versus day 15 and 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 Confirmed chronic pancreatitis 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: 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 32,0 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
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Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain

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