Clinical trial NCT01790555 (phase 2, status: unknown status)
Conditions: pain
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: namisol, diazepam/placebo
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)OC1=C2C(O)=CC(CCCCC)=C1, CN1C2=C(C=C(Cl)C=C2)C(=NCC1=O)C1=CC=CC=C1
Eligibility criteria:

        Inclusion criteria

          -  Patient is at least 18 years old on the day the informed consent form will be signed.

          -  Patient has persistent or intermittent abdominal pain due to underlying
             intra-abdominal pathology.

          -  If the patient uses concomitant analgesic medication the dosage intake is stable for
             at least two weeks prior to the day of screening. Stable dose intake is defined as a
             daily equivalent sum of intake according to medical prescription within a small
             deviation range as judged by the investigator.

          -  Patient is undergoing elective, open abdominal surgery with planned use of an epidural
             catheter. The surgical procedure has an estimated duration of at least two hours,
             excluding the time to induce anesthesia.

          -  Patient scores I to III in the American Society of Anesthesiologists physical status
             classification system (ASA I-III).

          -  Patient is willing and able to comply with the lifestyle guidelines, scheduled visits,
             treatment plan, laboratory tests and other trial procedures.

          -  Patient is able to speak, read and understand the local language of the
             investigational site, is familiar with the procedures of the study, and agrees to
             participate in the study program by giving oral and written informed consent prior to
             screening evaluations.

        Exclusion criteria

          -  Patient is ineligible for the anesthesia protocol, as judged by the investigator.

          -  Patient is undergoing (abdominal wall) surgery with mesh implantation.

          -  Patient used any cannabinoids (by smoking cannabis or oral intake) for at least one
             month prior to the day of screening.

          -  Patient has (a history of) a medical disorder that, in the opinion of the
             investigator, may interfere with the study or may pose a risk for the patient.

          -  Patient uses amitriptyline or other concomitant medication that, in the opinion of the
             investigator, may interfere with the study or may pose a risk for the patient.

          -  Patient demonstrates clinically significant deviations in the electrocardiogram (ECG)
             parameters at screening.

          -  Patient is at the moment of screening diagnosed with moderate to severe renal
             impairment as judged by the investigator.

          -  Patient is at the moment of screening diagnosed with moderate to severe hepatic
             failure as judged by the investigator.

          -  Patient has a presence or history of major psychiatric illness as judged by the
             investigator.

          -  Patient demonstrates clinically significant laboratory abnormalities that in the
             opinion of the investigator may increase the risk associated with trial participation
             or may interfere with the interpretation of the trial results.

          -  Patient has a history of sensitivity/idiosyncrasy to THC or diazepam, compounds
             related to these compounds, or to any other related drug used in the past.

          -  Patient demonstrates a positive urine drug screen at screening visit for THC, cocaine,
             MDMA, or amphetamines.

          -  Female patient intends to conceive a child, is pregnant or breastfeeding, or does not
             use acceptable birth control measures including oral contraceptives, intrauterine
             devices or mechanical methods during the course of the study.

          -  Patient participated in another investigational drug study within 90 days prior to the
             first dose and/or participated in more than 2 clinical trials in the last 365 days.