The AllTrials campaign is shining a spotlight on clinical trials that haven’t published results, one per week from now on in the BMJ. Read more about this new series in the BMJ.
The trials we write about will be one of those flagged by the FDAAA Compliance Tracker and, as of 14 September 2018, the EU TrialsTracker as overdue reporting results. We’re asking the hundreds of patient groups and thousands of people who are part of the AllTrials campaign to suggest trials they would like to see highlighted so the trials we publicise weekly could be on any treatment or any disease area.
We are publicising unreported clinical trials to get the results reported. We know this works. In February 2018 the team at the EBMDataLab which developed the tracker highlighted one unreported trial on their blog and 7 days later the research team responsible at Columbia University reported the results.
The FDAAA Compliance Tracker is aimed at trying to stop new clinical trials from going overdue. In the meantime, AllTrials is working to get missing results from old trials published – the results we need to make good decisions about today’s and tomorrow’s medicines. If you can help us with that, please consider donating to AllTrials.
Here are the Unreported Clinical Trials of the Week:
31 December 2018: NCT00713193 A late reported clinical trial to investigate whether the immunosuppresant cyclosporine could be an effective additional treatment for a condition that involves clots forming in blood vessels throughout the body. This late reporting trial was sponsored by Ohio State University in collaboration with FDA and submitted results 82 days late.
29 November 2018: 2008-000560-17 A reporte
6 November 2018: NCT02341430 A phase 4 trial involving 50 American adults with grade I or II hernias to investigate hernia wall repair with a composite mesh, sponsored by Anne Arundel Health System Research Institute in collaboration with Medtronic Minimally Invasive Therapies Group.
26 October 2018: NCT02633969 A non-randomised trial involving 30 children investigating the effectiveness of Indomethacin Capsules to treat pain following surgery. This unreported trial was sponsored by Iroko Pharmaceuticals.
10 October 2018: NCT02192827 A trial involving 254 participants between the ages of 2-20 investigating the effectiveness of the drug Dexamethasone in treating acute worsening of pediatric asthma. This trial is sponsored by The University at Buffalo.
27 September 2018: 2008-005167-33 A randomized trial involving 72 patients investigating the impact of the medication gabapentin in treatment of cerebral ataxia. This trial is sponsored by the Charité University Medicine Berlin.
13 September 2018: 2007-006729-28 A randomized trial involving 58 adults comparing the effectiveness of two medications for treatment of rheumatoid arthritis flare ups. This trial is sponsored by the Manchester University NHS Foundation Trust.
4 September 2018: NCT02186301, NCT02322281 Two trials involving a total of 249 patients with a particular type of lung cancer investigating the effectiveness of the drug rocilentinib in treatment of the cancer. Both of these trials were sponsored by Clovis Oncology Inc.
22 August 2018: NCT01656733 A phase 4 trial involving 154 pregnant women investigating nicotine replacement therapy for smoking cessation during pregnancy. This unreported trial was sponsored by UConn Health in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Pfizer provided in-kind support.
9 August 2018: NCT02128646 A trial involving 40 adults investigating the effectiveness of the drug Exparel in postoperative pain management following abdominal hernia surgery. This trial was sponsored by the study’s PI, Dr Michael Moncure from the University of Kansas Medical Center.
24 July 2018: NCT00674570 A randomized trial involving 138 adults investigating treatment to reduce fear in veterans with post-traumatic stress disorder. This trial was sponsored by the VA Office of Research and Development in the US.
18 July 2018: NCT01976936 A randomized trial involving 164 adult stroke patients investigating statin therapy as treatment to aid acute post-stroke recovery. This unreported trial was sponsored by the study PI, Dr. Mitchell S Elkind of Columbia University in collaboration with the National Institute of Neurological Disorders and Stroke.
10 July 2018: NCT02461745 A non-randomized trial involving 200 hepatitis C patients investigating the impact of antiviral medication on treatment of hepatitis C. This trial was sponsored by Kaiser Permanente in California, USA in collaboration with AbbVie.
3 July 2018: NCT01576783 A randomized trial involving 307 preterm babies to investigate the impact of fatty acid supplements on their development. This trial was run by Sara Keim PhD of Nationwide Children’s Hospital in Columbus, Ohio.
26 June 2018: NCT02045901 A multicenter trial with 128 pregnant adolescents investigating a drug for the treatment of pregnancy-induced nausea and vomiting. This trial was sponsored by Duchesnay Inc. in collaboration with Premier Research Group plc.
13 June 2018: NCT00450463 A randomized trial with 53 participants evaluating the effectiveness of vaccine therapy in combination with medication for treatment of prostate cancer. This unreported trial was sponsored by the National Cancer Institute in collaboration with the National Institutes of Health Clinical Center.
5 June 2018: NCT02504580, NCT02762929, NCT02689258 Three randomized trials with 1,170 enrolled participants investigating the role of the drug HTX-011 in treatment of post-operative pain after hernia surgery, bunion removal surgery, and tummy tuck surgery. All three trials were sponsored by Heron Therapeutics.
29 May 2018: NCT02111174 A randomized trial with 30 adults investigating the effects of electrical stimulation therapy for treatment of chemotherapy-induced pain. This trial was sponsored by the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital.
22 May 2018: NCT02097641 A randomized trial involving 60 adult participants with respiratory distress syndrome investigating the role of human stem cells in treatment of this syndrome. This unreported trial was sponsored by Dr. Michael Mattay of the University of California, San Francisco in collaboration with National Heart, Lung, and Blood Institute, Massachusetts General Hospital, Stanford University, the University of Pittsburgh, and the University of Minnesota.
15 May 2018: NCT01922258 A trial involving 270 seniors evaluating the effectiveness of an anti-psychotic medication to treat agitation associated with Alzheimer’s. This unreported trial was sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. in collaboration with H. Lundbeck A/S.
8 May 2018: NCT00515281 A double blind study with around 484 premature infants investigating the effects of inhaled nitric oxide on their brain development. This study was sponsored by the University of Chicago.
2 May 2018: NCT01010126 A non-randomized trial with 252 adults investigating the use of two cancer treatments. It was lead by Dr. Henry Pitot of the Mayo Clinic. This unreported trial was sponsored by the National Cancer Institute and funded under 17 separate NCI grant contracts.
25 April 2018: NCT02076893 A study involving 64 children investigating pain medication in tonsillectomies. The PI for this trial is Dr. Stefan J Friedrichsdorf and it was sponsored by the Children’s Hospitals and Clinics of Minnesota.
17 April 2018: NCT02752646 A randomized trial involving 200 cataract surgery patients to compare the tolerability of different anti-inflammatory eye-drops. This PI for this trial is at the Jules Stein Eye Institute at UCLA and it was sponsored by MDbackline LLC in collaboration with Alcon Research.
11 April 2018: NCT01535937 A randomized trial with 55 cocaine dependent adults to investigate whether ketamine is an effective treatment for cocaine addiction. The study was sponsored by New York State Psychiatric Institute in collaboration with the National Institute on Drug Abuse.
4 April 2018: NCT03115177 A study involving 56 adult patients investigating whether a commonly used antibiotic can prevent better infection after shoulder surgery than the standard treatment, sponsored by Rush University Medical Centre in Chicago.
26 March 2018: NCT0213326 A double blind trial of commonly used pain killers for relief of pain after tooth extraction involving 67 adults. It was run by Tufts University School of Medicine between 2014 and 2016.