Trial record 2 of 26 for:
Open Studies | "Pancreatitis, Chronic"
Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
This study is currently recruiting participants.
Verified November 2012 by Radboud University
Sponsor:
Radboud University
Collaborator:
European Union
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01551511
First received: February 7, 2012
Last updated: November 15, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatitis, Chronic Abdominal Pain Chronic Pain |
Drug: Tetrahydrocannabinol Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary pancreatitis
Drug Information available for:
Dronabinol
U.S. FDA Resources
Further study details as provided by Radboud University:
Primary Outcome Measures:
- Average VAS pain [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and day 52 ] [ Designated as safety issue: No ]Electroencephalogram; measuring evoked potentials to noxious electrical stimuli, evoked potentials to auditory stimuli (oddball), and FFT of spontaneous EEG.
- QST [ Time Frame: Baseline versus day 15 and day 52 ] [ Designated as safety issue: No ]Quantitative Sensory Testing; measuring pressure pain thresholds, electrical thresholds, electric wind-up response, and DNIC.
- Safety [ Time Frame: Baseline until follow-up (day 59-61) ] [ Designated as safety issue: Yes ]
- Laboratory
- ECG
- HF / BP
- Adverse events
- 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 ] [ Designated as safety issue: No ]THC, 11-OH-THC and THC-COOH concentrations
- Functional parameters [ Time Frame: Baseline until day 52 ] [ Designated as safety issue: No ]
- Body weight
- Supplementary feeding
- Quality of life [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]Quality of life will be evaluated by questionnaires
- Pharmacodynamics [ Time Frame: Baseline versus day 15 and day 52 ] [ Designated as safety issue: No ]Pharmacodynamics measured by body sway and questionnaires (VASBond & Lader and VASBowdle)
| Estimated Enrollment: | 68 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: delta-9-tetrahydrocannabinol (namisol) |
Drug: Tetrahydrocannabinol
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:
|
| Placebo Comparator: Placebo |
Drug: Placebo
Identical step-up approach to the Namisol arm.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551511
Contacts
| Contact: Marjan de Vries, MSc | 0031 24 3610903 | m.devries@chir.umcn.nl |
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands, 6500 HB | |
| Contact: Marjan de Vries, MSc m.devries@chir.umcn.nl | |
| Principal Investigator: Harry van Goor, MD PhD | |
| Principal Investigator: Oliver Wilder-Smith, MD PhD | |
| Sub-Investigator: Marjan de Vries, MSc | |
Sponsors and Collaborators
Radboud University
European Union
Investigators
| Principal Investigator: | Harry van Goor, MD PhD | Radboud University Nijmegen Medical Centre, department of surgery |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01551511 History of Changes |
| Other Study ID Numbers: | HEEL-2011-02 |
| Study First Received: | February 7, 2012 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
chronic pancreatitis abdominal pain visceral pain chronic pain |
Additional relevant MeSH terms:
|
Pancreatitis, Chronic Abdominal Pain Pancreatitis Stress, Psychological Pain Signs and Symptoms Signs and Symptoms, Digestive Pancreatic Diseases Digestive System Diseases Behavioral Symptoms Tetrahydrocannabinol |
Hallucinogens Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013