- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318369
Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain (Delta-pain)
July 8, 2013 updated by: Radboud University Medical Center
The Safety, Tolerability, and Analgesic Efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
The main goal of this trial is to study the efficacy of Namisol® after a single dose of Δ9-THC in the treatment of pain resulting from chronic pancreatitis.
Objective measures of pain processing, e.g.
encephalography (EEG) and quantitative sensory testing (QST), are included to provide insight in underlying nociceptive processing.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The most important symptom in chronic pancreatitis (CP) is abdominal pain.
Pancreatic pain 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 and reliable pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions.
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6500 HB
- Radboud University Nijmegen Medical Centre
-
-
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:
- Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
- Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain according ISAP (intermittent or persistent pain on a daily basis in at least 3 months)38, and consider their pain must as severe enough for medical treatment (average NRS ≥ 3).
- Patient in the opioid group takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the (principal) investigator.
- Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.
Exclusion Criteria:
- Patient used any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
- Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
- Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
- Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
- Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
- Patient uses any kind of concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals).
- Patient takes amitriptyline on a daily basis.
- Patient takes more than 20 mg benzodiazepines 6 hours prior or following intake of study medication (11 hour am) according prescription.
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: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Namisol
Namisol (dronabinol) single dose 8 mg
|
Single dose delta-9-tetrahydrocannabinol
Other Names:
|
Active Comparator: Diazepam
Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.
|
Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity (VAS pain)
Time Frame: Repeatedly; baseline until 6 hours after administration
|
Pain intensity (VAS pain at rest and on movement)
|
Repeatedly; baseline until 6 hours after administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG
Time Frame: Repeatedly; baseline until 6 hours after administration
|
Spontaneous EEG and evoked potentials to noxious electrical stimuli
|
Repeatedly; baseline until 6 hours after administration
|
QST
Time Frame: Repeatedly; baseline until 6 hours after administration
|
Quantitative Sensory Testing, using pressure pain tolerance and electrical thresholds
|
Repeatedly; baseline until 6 hours after administration
|
Body sway
Time Frame: Repeatedly; baseline until 6 hours after administration
|
Static body sway
|
Repeatedly; baseline until 6 hours after administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Harry van Goor, MD PhD, Radboud University Medical Center
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, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
March 9, 2011
First Submitted That Met QC Criteria
March 17, 2011
First Posted (Estimate)
March 18, 2011
Study Record Updates
Last Update Posted (Estimate)
July 9, 2013
Last Update Submitted That Met QC Criteria
July 8, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Pancreatic Diseases
- Abdominal Pain
- Pancreatitis
- Pancreatitis, Chronic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Antiemetics
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Neuromuscular Agents
- Hallucinogens
- Cannabinoid Receptor Agonists
- Cannabinoid Receptor Modulators
- Muscle Relaxants, Central
- Dronabinol
- Diazepam
Other Study ID Numbers
- HEEL-2011-01
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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