Condition category
Musculoskeletal Diseases
Date applied
12/02/2004
Date assigned
13/02/2004
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wadie Najm

ORCID ID

Contact details

101 The City Drive
Bldg 200 #512
Rt81
Orange
92868
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HS#2000-1046

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Arthritis

Intervention

Participants were randomised to receive SAMe or Celebrex over two months. Pain, quality of life and musculoskeletal measures were assessed before, during and after the study.

Intervention type

Drug

Phase

Not Specified

Drug names

S-Adenosyl methionine (SAMe), celecoxib

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

01/09/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Volunteers

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

61

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2000

Recruitment end date

01/09/2002

Locations

Countries of recruitment

United States of America

Trial participating centre

101 The City Drive
Orange
92868
United States of America

Sponsor information

Organisation

University of California, Irvine, Medical Center (UCIMC) (USA)

Sponsor details

300 University Tower
Irvine
92697
United States of America

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University of California, Irvine, Medical Center (UCIMC) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15102339

Publication citations

  1. Results

    Najm WI, Reinsch S, Hoehler F, Tobis JS, Harvey PW, S-adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: a double-blind cross-over trial. [ISRCTN36233495]., BMC Musculoskelet Disord, 2004, 5, 6, doi: 10.1186/1471-2474-5-6.

Additional files

Editorial Notes