A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00718081
• Date of registration: 16/07/2008
• Prospective Registration: Yes
• Primary sponsor: AcelRx Pharmaceuticals, Inc.
• Public title: A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
• Scientific title: A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
• Date of first enrolment: August 2008
• Target sample size: 88
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00718081
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria at Screening:

1. Male or female patients between 18 to 80 years of age.

2. Patient is scheduled to undergo an upper or lower abdominal surgery under general
anesthesia.

3. Patient must be classified as American Society of Anesthesiologists (ASA) class I -
III.

4. Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 18 and 39,
inclusively.

5. Female patients of childbearing potential must be using an effective method of birth
control from the screening visit through the end of study. Acceptable methods of birth
control include oral or transdermal contraceptives, condom, spermicidal foam,
intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring,
or sterilization of partner. The reason for non-childbearing potential, such as
bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for
=1 year, must be specified in the patient's case report form (CRF).

6. The patient must be willing and able to understand the study procedures and the use of
pain scales, and to communicate meaningfully with the study personnel.

7. The patient must provide written informed consent and sign the Informed Consent

Exclusion Criteria at Screening:

1. Patient is scheduled to undergo a laparoscopically-assisted abdominal surgery.

2. Patient has previously not responded to opioid analgesics for treatment of pain.

3. Patient is currently taking or has taken an opioid for more than 30 consecutive days
of daily use at a daily dose equivalent to greater than 15 mg morphine within the past
3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab®
with 5 mg hydrocodone per tablet).

4. Patient has an allergy or hypersensitivity to opioids.

5. Patient currently has sleep apnea that has been documented by a sleep laboratory
study.

6. Patient has any screening laboratory test value outside the laboratory normal range
which is considered clinically significant by the Investigator.

7. Patient is a woman who is pregnant or lactating.

8. Patient has psychiatric disease or encephalopathy severe enough to prevent patient
from providing reliable study documentation.

9. Patient, in the Investigator's judgment, does not have adequate ability to read and
understand English.

10. Patient has a medical condition that, in the Investigator's opinion, could adversely
impact the patient's participation or safety, conduct of the study, or interfere with
the pain assessments, including chronic abdominal pain or active infection.

11. Patient has clinically significant renal or liver impairment which could affect
metabolism or clearance of sufentanil.

12. Patient has a painful physical condition other than acute abdominal pain that, in the
opinion of the Investigator, may confound post-operative pain assessments.

13. Patient has a history of drug, prescription medicine, or alcohol abuse within the past
2 years or a positive drug screen test for cocaine, amphetamines, barbiturates,
phencyclidine, or methadone at screening.

14. Patient is receiving oxygen therapy at the time of screening.

15. Patient has participated in a clinical trial of an investigational drug or device
within 30 days of screening visit or is scheduled to receive an investigational
product other than ARX-F01 while participating in this study.

Exclusion Criteria at Randomization (during early PACU time period):

1. Patient has a respiratory rate that is less than 8 breaths per minute or greater than
24 breaths per minute.

2. Patient has arterial oxygen saturation by pulse oximetry (SpO2) of less than 90% with
supplemental oxygen.

3. Patient is not able to answer questions and follow commands.

4. Patient has vomiting that is not responsive to standard treatment.

5. The surgical procedure from incision to closure was longer than 4 hours.

6. There have been any deviations from the surgical or anesthetic protocols as specified
in Section 6.1.2.1.

approved by the Institutional Review Board (IRB).



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Major Upper or Lower Abdominal Surgery

Intervention(s)

Drug: Oral sufentanil

Drug: Placebo

Primary Outcome(s)

SPID-12 [Time Frame: 12 hours after surgery]

Secondary Outcome(s)

Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief [Time Frame: Up to 12 hours after surgery]

Secondary ID(s)

ARX-C-005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00718081