- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551511
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
October 27, 2014 updated by: Radboud University Medical Center
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nijmegen, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Identical step-up approach to the Namisol arm.
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Experimental: delta-9-tetrahydrocannabinol (namisol)
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average VAS pain
Time Frame: Baseline versus day 52
|
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.
|
Baseline versus day 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG
Time Frame: Baseline and day 52
|
Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.
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Baseline and day 52
|
QST
Time Frame: Baseline versus day 15 and day 52
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Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.
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Baseline versus day 15 and day 52
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Safety
Time Frame: Baseline until follow-up (day 59-61)
|
|
Baseline until follow-up (day 59-61)
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Pharmacokinetics
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
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THC, 11-OH-THC and THC-COOH concentrations
|
Predose levels at baseline, day 15 and day 52; postdose levels (30 min, 45 min, 60 min, 100 min) at day 15 and 52
|
Functional parameters
Time Frame: Baseline until day 52
|
|
Baseline until day 52
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Quality of life
Time Frame: Baseline versus day 52
|
Quality of life will be evaluated by questionnaires
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Baseline versus day 52
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Pharmacodynamics
Time Frame: Baseline versus day 15 and day 52
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Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
|
Baseline versus day 15 and day 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Harry van Goor, MD PhD, Radboud University Nijmegen Medical Centre, department of surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
March 7, 2012
First Posted (Estimate)
March 12, 2012
Study Record Updates
Last Update Posted (Estimate)
October 28, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Pancreatic Diseases
- Chronic Pain
- Abdominal Pain
- Pancreatitis
- Pancreatitis, Chronic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Psychotropic Drugs
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Dronabinol
Other Study ID Numbers
- HEEL-2011-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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