NCT00791739 is a Phase 4 clinical trial of trazodone, pregabalin in Fibromyalgia, sponsored by Universidad de Granada.

Who is sponsoring NCT00791739?

NCT00791739 is sponsored by Universidad de Granada.

What drugs are being tested in NCT00791739?

Interventions in NCT00791739: trazodone, pregabalin.

What condition does NCT00791739 study?

NCT00791739 studies Fibromyalgia.

Is NCT00791739 still recruiting?

NCT00791739 is currently completed. Last updated 1 December 2014.

Last reviewed 2014-12-01 · How we verify

NCT00791739

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II)

Completed Phase 4 Last updated 1 December 2014

What this trial tests

Phase 4 trial testing trazodone, pregabalin in Fibromyalgia in 66 participants. Completed in 1 October 2009.

Timeline

1 April 2008

Primary endpoint
1 July 2009

1 October 2009

Quick facts

Lead sponsor	Universidad de Granada
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	1 April 2008
Primary completion	1 July 2009
Estimated completion	1 October 2009
Sites	1 location across Spain

Drugs / interventions tested

trazodone, pregabalin — full drug profile →

Conditions studied

Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Universidad de Granada — full company profile →

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean decrease, from baseline to endpoint, in the Fibromyalgia Impact Questionnaire
Time frame: Baseline, 6, 12, 18 and 24 weeks

Sponsor's own description

The study has a double purpose: a first phase intends to assess the effectiveness and tolerability of trazodone, an antidepressant with sedative and sleep-promoting properties, in the treatment of fibromyalgia; a second phase intends to evaluate if the addition of pregabalin to patients who have shown a partial response to trazodone additionally improves fibromyalgia symptomatology.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.
Calandre EP, Morillas-Arques P, Molina-Barea R, Rodriguez-Lopez CM, et al · · 2011 · cited 27× · PMID 21575194 · DOI 10.1186/1471-2474-12-95

Verify or expand the search:

Other recruiting trials for Fibromyalgia

Currently open trials in the same condition.

NCT02285868 — ATI Evidence-based Guide Investigating Clinical Services · active not recruiting
NCT07245303 — Neural Mechanisms of Light Driven Analgesia · NA · recruiting
NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
NCT07358754 — The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor · recruiting
NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia · NA · recruiting

Other Universidad de Granada trials

Trials by the same sponsor.

NCT07497698 — Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults · NA · recruiting
NCT07528924 — TuJugling: Comparing Two Juggling Learning Methods in College Students · NA · recruiting
NCT07388134 — Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain · NA · active not recruiting
NCT07494916 — Effects of Functional Task Training on Muscle Health and Function in Older Adults With Sarcopenia · NA · active not recruiting
NCT06518200 — Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00791739 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Universidad de Granada
Last refreshed: 1 December 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00791739.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing