This page lists RIAT restorations to date as well as proposed RIAT projects.
Completed RIAT restorations
| Trial | Intervention(s) studied | Original publication | RIAT restoration |
|---|---|---|---|
| “8-way” Bendectin Study | Doxylamine, Pyridoxine and Dicyclomine | unpublished – invisible | 2017 |
| Paroxetine study 329 continuation phase | Paroxetine, imipramine, and placebo | 2001 | 2016 |
| Paroxetine study 329 | Paroxetine, imipramine, and placebo | 2001 | 2015 |
| CEA Second-Look Trial | ‘Second-look’ surgery with intention to remove any recurrence discovered | unpublished – invisible | 2014 |
| B1Y-MC-HCJE | Fluoxetine for acute treatment of depression in children and adolescents | 2002 | 2022 (full text PDF) |
| B1Y-MC-X065 | Fluoxetine in children and adolescents with depression | 1997 | 2022 (full text PDF) |
| FOURIER trial | Evolocumab and clinical outcomes in patients with cardiovascular disease | 2017 | 2022 |
| Study PRGF (BTI-01-EC/07/ART) | Plasma Rich in Growth Factors (PRGF-Endoret) in the short-term treatment of symptomatic knee osteoarthritis | 2012 | 2023 |
Proposed RIAT restorations
| Sponsor & Study | Concern | Point of contact | Data available | Date of entry in RIAT database | Calls to action & Responses |
|---|---|---|---|---|---|
| Sponsor and trial ID: Parke-Davis and Pfizer, Studies 945-210, 945-224, 945-400, 945-430-295, 945-430-306, 9451008
Title: A Double-Blind Placebo-Controlled Trial of Gabapentin for Treatment of Painful Diabetic Peripheral Neuropathy; Double-Blind, Randomized, Placebo-Controlled, Parallel Groups, Multi-Center Trial to Determine the Efficacy and Safety of Neurontin (Gabapentin) in Subjects with Peripheral Neuropathy (Post-Herpetic Neuralgia); A Double-Blind Placebo-Controlled Trial with 3 Doses of Gabapentin for Treatment of Painful Diabetic Neuropathy; A Double Blind Placebo Controlled Trial of Gabapentin for the Treatment of Patients Exhibiting Symptoms of Neuropathic Pain; A Double-Blind Placebo Controlled Trial of Gabapentin for the Treatment of Post Herpetic Neuralgia; A 15 Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study of Neurontin (Gabapentin) for Efficacy and Quality of Life in Patients with Painful Diabetic Peripheral Neuropathy Study dates: 1996-2003 |
Distortion (misreporting) | Evan Mayo-Wilson | CSRs, IPD, Protocols and blank CRFs | August 30, 2019 | August 30, 2019 Call to Action |
| Sponsor and trial ID: National Institute of Mental Health (NIMH) study NCT00021528
Title: Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Study dates: 2001 to 2006 |
Distortion (misreporting) | H. Edmund Pigott | IPD, protocol, and SAP | March 13, 2019 | March 6, 2019 Call to Action |
| Sponsor and trial ID: Merck study V501-015 NCT00092534
Title: A Randomized Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16-/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18] Ll Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women – The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease) Study dates: 2002 to 2007 |
Invisibility (unpublished methodology) and distortion (misreporting) | Peter Doshi | CSR | January 11, 2019 | Jan 11, 2019 Call to Action |
| Sponsor and trial ID: Merck study V501-019 NCT00090220
Title: Safety, Immunogenicity, and Efficacy of GARDASIL™ (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) in Study dates: 2004 to 2009 |
Invisibility (unpublished methodology) and distortion (misreporting) | Peter Doshi | CSR | January 11, 2019 | Jan 11, 2019 Call to Action |
| Sponsor and trial ID: Forest Laboratories’ study CIT-MD-18
Title: A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents Study dates: 1999 to 2002 |
Distortion (misreporting) | Leemon McHenry | Protocol & partial CSR | June 15, 2018 | June 13, 2018 Call to Action |
| Sponsor and trial ID: Pfizer trial 050-113
Title: The Effects of Sertraline Compared with Placebo on the Body Weights of Patients with Non-Insulin-Dependent Diabetes Mellitus Study dates: Oct 1998 to Jan 1992 |
Invisible (unpublished) | Tarang Sharma | ~100 pages from main body of CSR | June 15, 2018 | June 8, 2018 Call to Action |
| Sponsor and trial ID: US National Institute of Mental Health (NIMH) study NCT00006286
Title: Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial Study dates: 2000 to 2003 |
Distortion (misreporting) | Jon Jureidini | Protocol & IPD | June 4, 2018 | May 28, 2018 Call to Action |
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