Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients

NCT02989597 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016-6985
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (30)

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  Preoperatively

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  4 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  8 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  12 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  16 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  20 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  24 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  28 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  32 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  36 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  40 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  44 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  48 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  52 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  56 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  60 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  64 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  68 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  72 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  76 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  80 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  84 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  88 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  92 hours after surgery

• Overall Health-related Quality of Life (SF-36)

  The Short Form-36 (SF-36) health survey will be used as an indicator of overall health status. The SF-36 is a self-reported questionnaire which measures eight scaled scores: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Likert scales and yes/no options are used to assess function and well-being. Scales are standardized to obtain a score ranging from 0-100. Higher scores are indicative of better health status, and a mean score of 50 has been articulated as a normative value for all scales.

  96 hours after surgery

• Time to First Ambulation

  Unit: days. Assessments of patients' time to first ambulation post-operatively

  Immediately postoperatively until ambulation, on average 3-4 days

• Time to Discharge From Hospital

  Unit: days. Measured at patient discharge (=length of stay)

  Immediately postoperatively until patient discharge, on average 1 week, up to 1 month

• Total Narcotic Dose in the Hospital

  Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)

  Intraoperatively until patient discharge, on average 1 week, up to 1 month

• Frequency of Narcotic Usage

  Unit: number. Frequency of narcotics used intra-operatively until study completion (patient discharge)

  Intraoperatively until patient discharge, on average 1 week, up to 1 month

• Patient Disposition at Discharge

  Level of rehabilitative care deemed to be required (upon patient discharge)

  At patient discharge, on average 1 week, up to 1 month

Secondary Outcomes (2)

• Post-operative Course of Dexamethasone

  Intraoperatively through patient discharge, on average 1 week, up to 1 month

• Assessment of Lumbar Fusion

  3-6 months

Study Arms (2)

Intra-operative Methadone Hydrochloride

EXPERIMENTAL

Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise

Drug: Methadone Hydrochloride; Other: Standard pain regimen; Procedure: Spinal Fusion Surgery; Drug: Dexamethasone; Drug: Ketamine; Drug: Remifentanil; Drug: Sufentanil

Control

ACTIVE COMPARATOR

Patients administered standard of care

Other: Standard pain regimen; Procedure: Spinal Fusion Surgery; Drug: Dexamethasone; Drug: Ketamine; Drug: Remifentanil; Drug: Sufentanil

Interventions

Methadone Hydrochloride DRUG

IV administration of methadone intra-operatively for a single dose

Intra-operative Methadone Hydrochloride

Standard pain regimen OTHER

Standard medications for pain control administered after spinal surgery to be either fentanyl or morphine

Control; Intra-operative Methadone Hydrochloride

Spinal Fusion Surgery PROCEDURE

Clinically-indicated spinal fusion surgery

Control; Intra-operative Methadone Hydrochloride

Dexamethasone DRUG

Post operative swelling and pain control

Control; Intra-operative Methadone Hydrochloride

Ketamine DRUG

Perioperative anesthesia medication

Control; Intra-operative Methadone Hydrochloride

Remifentanil DRUG

Perioperative pain medication

Control; Intra-operative Methadone Hydrochloride

Sufentanil DRUG

Perioperative pain medication

Control; Intra-operative Methadone Hydrochloride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets age criteria, age between 18-80
• Undergoing lumbar fusion surgery, one or two spinal levels
• ASA (American Society of Anesthesiologists) grades I-III

You may not qualify if:

• Patient outside of age criteria
• Renal failure requiring dialysis
• Serum creatinine greater than 2.0
• Hepatic dysfunction with liver function tests greater than twice the upper limit
• Pulmonary disease requiring home oxygen therapy
• Obstructive sleep apnea
• Severe heart disease
• Allergy to methadone, morphine, or fentanyl
• Recent or distant history of opioid abuse
• Poorly managed psychiatric illness
• Known history of alcohol abuse
• Morbid obesity (body mass index \> 50 kg/m2)
• Treatment with other NMDA receptor antagonists
• Prolonged QTc (corrected QT interval) on pre-operative EKG,
• Refusal or inability to sign the consent form

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (11)

• Inturrisi CE. Pharmacology of methadone and its isomers. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):435-7.

  PMID: 16012416 BACKGROUND

• Lugo RA, Satterfield KL, Kern SE. Pharmacokinetics of methadone. J Pain Palliat Care Pharmacother. 2005;19(4):13-24.

  PMID: 16431829 BACKGROUND

• Stemland CJ, Witte J, Colquhoun DA, Durieux ME, Langman LJ, Balireddy R, Thammishetti S, Abel MF, Anderson BJ. The pharmacokinetics of methadone in adolescents undergoing posterior spinal fusion. Paediatr Anaesth. 2013 Jan;23(1):51-7. doi: 10.1111/pan.12021. Epub 2012 Sep 14.

  PMID: 22978825 BACKGROUND

• Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.

  PMID: 22037641 BACKGROUND

• Pacreu S, Fernandez Candil J, Molto L, Carazo J, Fernandez Galinski S. The perioperative combination of methadone and ketamine reduces post-operative opioid usage compared with methadone alone. Acta Anaesthesiol Scand. 2012 Nov;56(10):1250-6. doi: 10.1111/j.1399-6576.2012.02743.x. Epub 2012 Jul 26.

  PMID: 22834921 BACKGROUND

• Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.

  PMID: 25837528 BACKGROUND

• Jacobson L, Chabal C, Brody MC, Ward RJ, Ireton RC. Intrathecal methadone and morphine for postoperative analgesia: a comparison of the efficacy, duration, and side effects. Anesthesiology. 1989 May;70(5):742-6. doi: 10.1097/00000542-198905000-00005.

  PMID: 2655501 BACKGROUND

• Gourlay GK, Willis RJ, Wilson PR. Postoperative pain control with methadone: influence of supplementary methadone doses and blood concentration--response relationships. Anesthesiology. 1984 Jul;61(1):19-26.

  PMID: 6742480 BACKGROUND

• Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

  PMID: 20418538 BACKGROUND

• Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.

  PMID: 22063370 BACKGROUND

• Russell T, Mitchell C, Paech MJ, Pavy T. Efficacy and safety of intraoperative intravenous methadone during general anaesthesia for caesarean delivery: a retrospective case-control study. Int J Obstet Anesth. 2013 Jan;22(1):47-51. doi: 10.1016/j.ijoa.2012.10.007. Epub 2012 Dec 7.

  PMID: 23219678 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Dexamethasone; Ketamine; Remifentanil; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl

Results Point of Contact

• Title: Dr. Andrew J. Kobets
• Organization: Montefiore Medical Center

akobets@montefiore.org

718-920-7400

Study Officials

• Andrew J Kobets, MD, MHS

  Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Merritt D Kinon, MD

  Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 12, 2016
• Study Start: July 29, 2017
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: May 22, 2023
• Results First Posted: April 25, 2023

Record last verified: 2023-04

Locations

US (1)