NCT00239395

Brief Summary

The objective of this trial was to assess the efficacy and safety of 7.5 mg meloxicam i.m. once daily compared with 7.5 mg meloxicam tablets once daily p.o. in patients with osteoarthritis over a time period of 7 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

October 13, 2005

Last Update Submit

October 31, 2013

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Pain on active movement by VAS.

    day 0, day 7

Secondary Outcomes (13)

  • Pain at rest

    up to 7 days

  • Patient status with regard to change of arthritic condition

    up to 7 days

  • Withdrawals due to inadequate efficacy

    up to 7 days

  • Onset of Analgesic action

    up to 7 days

  • Time to maximum pain relief

    up to 7 days

  • +8 more secondary outcomes

Interventions

Meloxicam ampouleDRUG
Meloxicam tabletDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 years or above
  • Patients suffering from acute and painful exacerbation of osteoarthritis of the hip or knee.
  • The diagnosis must be based on
  • clinical signs and symptoms or
  • x-ray diagnosis plus clinical signs and symptoms
  • Assessment of pain on active movement (by the patient) must exceed 40 mm on a 100 mm visual analogue scale (VAS)
  • Symptoms of OA requiring administration of NSAIDs
  • Willingness and ability to provide written informed consent.

You may not qualify if:

  • Known or suspected hypersensitivity to the trial drugs or their excipients, analgesics, antipyretics or NSAIDs
  • Any clinical evidence of active peptic ulceration during the last six months
  • Pregnancy or breastfeeding (precaution : attention should be drawn to reports that NSAIDs were reported to decrease the effectivity of intrauterine devices)
  • Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
  • Concomitant treatment with anti-coagulants (including heparin), lithium
  • Concomitant administration of other NSAIDs or analgesic agents (except paracetamol up to 4g/day)
  • Administration of any NSAID during the last 2 days (3 days for any oxicam) prior to the first administration of the trial drug
  • Concomitant treatment with an oral corticosteroid initiated or with an altered dose over the previous month
  • Parenteral or intraarticular administration of corticosteroids in the previous month
  • Any i.m. injection during the previous 7 days
  • Any contra-indication to i.m. injections
  • Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance, ulcerative colitis
  • Any other rheumatological or non-rheumatological disease that could interfere with the evaluation of efficacy and safety
  • Serum creatinine 125 % of the upper limit of normal range ; aspartate transferase (AST/SGOT) and/or alkaline transferase (ALT/SGPT) 200 % of the upper limit of normal range
  • Platelet count \< 100,000/mm3 ; leucocytes count \< 3,000/mm3
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

People's Hospital, Beijing University

Beijing, 100044, China

Location

Beijing Xuan Wu Hospital

Beijing, 100050, China

Location

1st Affiliated, Anhui Medical University

Hefei City, Anhui Province, 230022, China

Location

Qilu Hospital, Shang Dong University

Nanzhou, 250012, China

Location

Shanghai Renji Hospital

Shanghai, 200001, China

Location

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

Shanghai Guanghai Hospital

Shanghai, 200052, China

Location

Shanghai Changhai Hospital

Shanghai, 200443, China

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim Shanghai

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

CN(8)