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

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01562483
First received: March 7, 2012
Last updated: October 27, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Postsurgical Pain
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: The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain; a Randomized, Double Blinded, Placebo-controlled, Experiment

Resource links provided by NLM:


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 pain diary.


Secondary Outcome Measures:
  • Electroencephalogram (EEG) [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline versus day 15 and day 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]
    Depression and (pain related) anxiety measured by questionnaires.

  • Pharmacodynamic parameters [ 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)

  • Safety parameters [ Time Frame: Baseline until follow-up (day 59-61) ] [ Designated as safety issue: Yes ]
    • Laboratory
    • Electrocardiogram (ECG)
    • Heart Frequency (HF) / Blood Pressure (BP)
    • Adverse Events (AE)

  • Quality of life [ Time Frame: Baseline versus day 52 ] [ Designated as safety issue: No ]
    Quality of life will be evaluated by questionnaires


Enrollment: 36
Study Start Date: October 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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:
  • Namisol
  • Dronabinol
Placebo Comparator: Placebo Drug: Placebo
Identical 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562483

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
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: NCT01562483     History of Changes
Other Study ID Numbers: HEEL-2011-03
Study First Received: March 7, 2012
Last Updated: October 27, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
postsurgical pain
abdominal pain
visceral pain
chronic pain

Additional relevant MeSH terms:
Abdominal Pain
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Analgesics
Dronabinol
Analgesics, Non-Narcotic
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Central Nervous System Agents
Hallucinogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014